FDA Approvals & News
Simplified MRSA Detection Test FDA Cleared
Through its BD Diagnostics segment, BD (Becton, Dickinson and Company) has received FDA 510(k) clearance of its simplified test for the detection of methicillin-resistant Staphylococcus aureus (MRSA).
The BBL CHROMagar MRSA product is a prepared plated medium that simplifies the process, decreases the time to result and offers high sensitivity and specificity for MRSA identification.
This new test, which allows for the direct detection and identification of most MRSA within 24 hours, enables microbiology laboratories to identify patients colonized with MRSA more quickly and easily than the processes currently available. The cost benefits associated with reducing nosocomial infections are said to be significant.
Medicis’ Wrinkle Injection Treatment Application FDA-Denied
Determining that its application was not “sufficiently complete,” the FDA has turned down Medicis Pharmaceutical’s application for Reloxin, a botulinum toxin type A.
According to Medicis, the FDA said the application didn’t address how Medicis would fulfill its responsibilities as the manufacturer of the product, and noted that the application included letters of authorization supporting a separate application submitted by French drugmaker Ipsen.
Medicis said it intends to “promptly” work with the FDA and coordinate its activities with Ipsen to address these administrative issues. In a study recently published in The New England Journal of Medicine, a group of investigators led by Amy Paller, M.D., of Northwestern University School of Medicine, found that children and adolescents with moderate to severe plaque psoriasis who received treatment with etanercept (Enbrel) experienced significant improvements in the signs and symptoms of their disease.
Other Drug News
Significant Improvement in Moderate to Severe Plaque Psoriasis with Enbrel in Children and Adolescents
In a study recently published in The New England Journal of Medicine, a group of investigators led by Amy Paller, M.D., of Northwestern University School of Medicine, found that children and adolescents with moderate to severe plaque psoriasis who received treatment with etanercept (Enbrel) experienced significant improvements in the signs and symptoms of their disease.
Study Method
The 48-week Phase III study was designed to assess the safety and efficacy of Enbrel therapy in children and adolescents between 4 and 17 years old with moderate to severe plaque psoriasis whose disease had been inadequately controlled with topical therapy or who received systemic therapy or phototherapy.
The study involved a total of 211 pediatric, with 106 patients initially randomized to receive 12 once-weekly weight-based doses of Enbrel (0.8 mg/kg up to the intended dose of 50 mg) and 105 patients randomized to receive placebo.
After this double-blind portion, 208 patients entered a 24-week period of open-label Enbrel treatment once-weekly.
At week 36, 138 patients were re-randomized to receive either Enbrel or placebo, to investigate withdrawal and re-treatment.
During the 48-week study, the percentage of patients achieving 75% or greater disease improvement from baseline, as measured by the standard Psoriasis Area and Severity Index (PASI 75), was used to evaluate the efficacy of Enbrel in patients between 4 and 17 years old. The primary efficacy endpoint was PASI 75 at week 12.
Findings
At week 12, which was the conclusion of the double-blind, placebo-controlled portion of the study, 57% (n=60) of pediatric patients treated with Enbrel achieved PASI 75, compared with 11% (n=12) of pediatric patients who received placebo (p<0.001).
At week 36, after 24 weeks of open-label treatment during which all patients in the study received Enbrel, PASI 75 was achieved by 68 percent (n=71) of the patients initially treated with Enbrel from the start of the study and 65 percent (n=67) of those who initially received placebo from the start of the study.
At the end of open-label treatment (week 36), 138 patients were re-randomized to receive either Enbrel or placebo. During this period, patients who lost PASI 75 were re-treated, and no patient had a rebound of psoriasis or a change in their type of psoriasis.
No serious adverse events or serious infections occurred during the 12-week placebo-controlled period, and rates of adverse events were similar for Enbrel and placebo. The most common adverse events observed during the 48-week trial in patients treated with Enbrel were upper respiratory tract infection, headache, and nasopharyngitis.
Paller AS et al for the Etanercept Pediatric Psoriasis Study Group. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med. 2008;358:241-251.
Botox Under Safety Review
The FDA has issued a statement that botulinum toxin A and B are under review following reports of serious adverse events, including 16 deaths.
The review was prompted by a call to action made late last month by the watchdog group Public Citizen saying that the government should place Black Box warnings on Botox (Allergan) and Myobloc (Solstice Neuroscience Inc.). Public Citizen also called for a consumer-friendly guide to be handed out to patients before they undergo treatment.
According to Public Citizen, which reviewed 180 reports submitted to the FDA by the manufacturers of Botox and Myobloc, 16 deaths occurred in patients undergoing treatment with one of the two products. In addition, complications such as difficulty swallowing and aspiration pneumonia, were also reported. Most of the deaths, according to the FDA, were in patients — including some children — who had undergone treatment for cerebral palsy- associated limb spasticity. Use of botulinum toxin for this purpose is unapproved in both children and adults.
In an address given by Public Citizen, according to a release from Allergan, the consumer group had alluded to one death that resulted from Botox Cosmetic. However, no deaths have been linked to the use of Botox Cosmetic, Allergan noted in a company statement. In addition, Allergan maintained that serious adverse events associated with therapeutic use of Botox are rare, and that they are highlighted on the drug’s packaging.
For more information regarding the FDA’s safety review, visit www.fda.gov/medwatch/safety/2008/safety08.htm#botox. /p>
2008 Allergen of the Year: Nickel
By Sharon Jacob, M.D.
This is the first time that nickel has been designated allergen of the year — despite its long reign as the number-one diagnosed allergen in patch-tested populations. The allergen of the year is designated by the American Contact Dermatitis Society based on growing prevalence data and/or novel/impactful exposure sources.
It is alarming that nickel has recently significantly separated itself from the other top allergen contenders. The North American Contact Dermatitis Group reported a positive patch-test prevalence rate to nickel as 10.5% (1985 to 1990), and in the latest data this prevalence has increased to 18.8% (2003 to 2004). Even more disturbing is that a significant number of those affected are children. Children can have the classic presentation of nickel reactions on the earlobes, neck, wrists and infraumbilical area, but there are also non-typical presentations, such as the one Belsito et al coined the “school chair sign”1 on the posterior thighs.
In 1992 the Danish Ministry on Environmental Legislation dictated a maximal allowable release of nickel from personal effects (such as earring posts) and found their sensitization rates dropped from 19% to 5.7%. Following this, the European Union issued a “nickel directive” to effect this same change. We have seen sensitization rates growing in the United States, and it is time for us to also take action, as well.
For more in-depth information about this infamous allergen, see this month’s issue of Dermatitis and refer to the article “Contact Allergen of the Year: Nickel” by Rachel Kornik and Kathryn A. Zug. [chart image]
Dr. Jacob is Assistant Professor of Medicine and Pediatrics (Dermatology) at the University of California, San Diego. She is also the Chair, Public Relations Committee for the American Contact Dermatitis Society.
Reference 1. Samimi SS, Siegfried E, Belsito DV. A diagnostic pearl: the school chair sign. Cutis. 2004 Jul;74(1):27-8.
In Brief…
COLLAGENEX PHARMACEUTICALS INITIATES… Phase II dose finding study of Becocalcidiol for the treatment of psoriasis. The double-blinded, placebo- and active-controlled study will evaluate the safety and efficacy of becocalcidiol using three concentrations of the compound administered once daily versus a vehicle and active control over a 12-week period.
AESTHETIC TECHNOLOGIES ANNOUNCES… An agreement with Cosmetrex partnership to provide microdermabrasion equipment to the cosmetic surgery industry. Under terms of the agreement, Cosmetrex members will have access to Aesthetic Technologies’ Parisian Peel Medical Microdermabrasion equipment, supplies and services through its strategic supply chain.
FDA Approvals & News
Simplified MRSA Detection Test FDA Cleared
Through its BD Diagnostics segment, BD (Becton, Dickinson and Company) has received FDA 510(k) clearance of its simplified test for the detection of methicillin-resistant Staphylococcus aureus (MRSA).
The BBL CHROMagar MRSA product is a prepared plated medium that simplifies the process, decreases the time to result and offers high sensitivity and specificity for MRSA identification.
This new test, which allows for the direct detection and identification of most MRSA within 24 hours, enables microbiology laboratories to identify patients colonized with MRSA more quickly and easily than the processes currently available. The cost benefits associated with reducing nosocomial infections are said to be significant.
Medicis’ Wrinkle Injection Treatment Application FDA-Denied
Determining that its application was not “sufficiently complete,” the FDA has turned down Medicis Pharmaceutical’s application for Reloxin, a botulinum toxin type A.
According to Medicis, the FDA said the application didn’t address how Medicis would fulfill its responsibilities as the manufacturer of the product, and noted that the application included letters of authorization supporting a separate application submitted by French drugmaker Ipsen.
Medicis said it intends to “promptly” work with the FDA and coordinate its activities with Ipsen to address these administrative issues. In a study recently published in The New England Journal of Medicine, a group of investigators led by Amy Paller, M.D., of Northwestern University School of Medicine, found that children and adolescents with moderate to severe plaque psoriasis who received treatment with etanercept (Enbrel) experienced significant improvements in the signs and symptoms of their disease.
Other Drug News
Significant Improvement in Moderate to Severe Plaque Psoriasis with Enbrel in Children and Adolescents
In a study recently published in The New England Journal of Medicine, a group of investigators led by Amy Paller, M.D., of Northwestern University School of Medicine, found that children and adolescents with moderate to severe plaque psoriasis who received treatment with etanercept (Enbrel) experienced significant improvements in the signs and symptoms of their disease.
Study Method
The 48-week Phase III study was designed to assess the safety and efficacy of Enbrel therapy in children and adolescents between 4 and 17 years old with moderate to severe plaque psoriasis whose disease had been inadequately controlled with topical therapy or who received systemic therapy or phototherapy.
The study involved a total of 211 pediatric, with 106 patients initially randomized to receive 12 once-weekly weight-based doses of Enbrel (0.8 mg/kg up to the intended dose of 50 mg) and 105 patients randomized to receive placebo.
After this double-blind portion, 208 patients entered a 24-week period of open-label Enbrel treatment once-weekly.
At week 36, 138 patients were re-randomized to receive either Enbrel or placebo, to investigate withdrawal and re-treatment.
During the 48-week study, the percentage of patients achieving 75% or greater disease improvement from baseline, as measured by the standard Psoriasis Area and Severity Index (PASI 75), was used to evaluate the efficacy of Enbrel in patients between 4 and 17 years old. The primary efficacy endpoint was PASI 75 at week 12.
Findings
At week 12, which was the conclusion of the double-blind, placebo-controlled portion of the study, 57% (n=60) of pediatric patients treated with Enbrel achieved PASI 75, compared with 11% (n=12) of pediatric patients who received placebo (p<0.001).
At week 36, after 24 weeks of open-label treatment during which all patients in the study received Enbrel, PASI 75 was achieved by 68 percent (n=71) of the patients initially treated with Enbrel from the start of the study and 65 percent (n=67) of those who initially received placebo from the start of the study.
At the end of open-label treatment (week 36), 138 patients were re-randomized to receive either Enbrel or placebo. During this period, patients who lost PASI 75 were re-treated, and no patient had a rebound of psoriasis or a change in their type of psoriasis.
No serious adverse events or serious infections occurred during the 12-week placebo-controlled period, and rates of adverse events were similar for Enbrel and placebo. The most common adverse events observed during the 48-week trial in patients treated with Enbrel were upper respiratory tract infection, headache, and nasopharyngitis.
Paller AS et al for the Etanercept Pediatric Psoriasis Study Group. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med. 2008;358:241-251.
Botox Under Safety Review
The FDA has issued a statement that botulinum toxin A and B are under review following reports of serious adverse events, including 16 deaths.
The review was prompted by a call to action made late last month by the watchdog group Public Citizen saying that the government should place Black Box warnings on Botox (Allergan) and Myobloc (Solstice Neuroscience Inc.). Public Citizen also called for a consumer-friendly guide to be handed out to patients before they undergo treatment.
According to Public Citizen, which reviewed 180 reports submitted to the FDA by the manufacturers of Botox and Myobloc, 16 deaths occurred in patients undergoing treatment with one of the two products. In addition, complications such as difficulty swallowing and aspiration pneumonia, were also reported. Most of the deaths, according to the FDA, were in patients — including some children — who had undergone treatment for cerebral palsy- associated limb spasticity. Use of botulinum toxin for this purpose is unapproved in both children and adults.
In an address given by Public Citizen, according to a release from Allergan, the consumer group had alluded to one death that resulted from Botox Cosmetic. However, no deaths have been linked to the use of Botox Cosmetic, Allergan noted in a company statement. In addition, Allergan maintained that serious adverse events associated with therapeutic use of Botox are rare, and that they are highlighted on the drug’s packaging.
For more information regarding the FDA’s safety review, visit www.fda.gov/medwatch/safety/2008/safety08.htm#botox. /p>
2008 Allergen of the Year: Nickel
By Sharon Jacob, M.D.
This is the first time that nickel has been designated allergen of the year — despite its long reign as the number-one diagnosed allergen in patch-tested populations. The allergen of the year is designated by the American Contact Dermatitis Society based on growing prevalence data and/or novel/impactful exposure sources.
It is alarming that nickel has recently significantly separated itself from the other top allergen contenders. The North American Contact Dermatitis Group reported a positive patch-test prevalence rate to nickel as 10.5% (1985 to 1990), and in the latest data this prevalence has increased to 18.8% (2003 to 2004). Even more disturbing is that a significant number of those affected are children. Children can have the classic presentation of nickel reactions on the earlobes, neck, wrists and infraumbilical area, but there are also non-typical presentations, such as the one Belsito et al coined the “school chair sign”1 on the posterior thighs.
In 1992 the Danish Ministry on Environmental Legislation dictated a maximal allowable release of nickel from personal effects (such as earring posts) and found their sensitization rates dropped from 19% to 5.7%. Following this, the European Union issued a “nickel directive” to effect this same change. We have seen sensitization rates growing in the United States, and it is time for us to also take action, as well.
For more in-depth information about this infamous allergen, see this month’s issue of Dermatitis and refer to the article “Contact Allergen of the Year: Nickel” by Rachel Kornik and Kathryn A. Zug. [chart image]
Dr. Jacob is Assistant Professor of Medicine and Pediatrics (Dermatology) at the University of California, San Diego. She is also the Chair, Public Relations Committee for the American Contact Dermatitis Society.
Reference 1. Samimi SS, Siegfried E, Belsito DV. A diagnostic pearl: the school chair sign. Cutis. 2004 Jul;74(1):27-8.
In Brief…
COLLAGENEX PHARMACEUTICALS INITIATES… Phase II dose finding study of Becocalcidiol for the treatment of psoriasis. The double-blinded, placebo- and active-controlled study will evaluate the safety and efficacy of becocalcidiol using three concentrations of the compound administered once daily versus a vehicle and active control over a 12-week period.
AESTHETIC TECHNOLOGIES ANNOUNCES… An agreement with Cosmetrex partnership to provide microdermabrasion equipment to the cosmetic surgery industry. Under terms of the agreement, Cosmetrex members will have access to Aesthetic Technologies’ Parisian Peel Medical Microdermabrasion equipment, supplies and services through its strategic supply chain.
FDA Approvals & News
Simplified MRSA Detection Test FDA Cleared
Through its BD Diagnostics segment, BD (Becton, Dickinson and Company) has received FDA 510(k) clearance of its simplified test for the detection of methicillin-resistant Staphylococcus aureus (MRSA).
The BBL CHROMagar MRSA product is a prepared plated medium that simplifies the process, decreases the time to result and offers high sensitivity and specificity for MRSA identification.
This new test, which allows for the direct detection and identification of most MRSA within 24 hours, enables microbiology laboratories to identify patients colonized with MRSA more quickly and easily than the processes currently available. The cost benefits associated with reducing nosocomial infections are said to be significant.
Medicis’ Wrinkle Injection Treatment Application FDA-Denied
Determining that its application was not “sufficiently complete,” the FDA has turned down Medicis Pharmaceutical’s application for Reloxin, a botulinum toxin type A.
According to Medicis, the FDA said the application didn’t address how Medicis would fulfill its responsibilities as the manufacturer of the product, and noted that the application included letters of authorization supporting a separate application submitted by French drugmaker Ipsen.
Medicis said it intends to “promptly” work with the FDA and coordinate its activities with Ipsen to address these administrative issues. In a study recently published in The New England Journal of Medicine, a group of investigators led by Amy Paller, M.D., of Northwestern University School of Medicine, found that children and adolescents with moderate to severe plaque psoriasis who received treatment with etanercept (Enbrel) experienced significant improvements in the signs and symptoms of their disease.
Other Drug News
Significant Improvement in Moderate to Severe Plaque Psoriasis with Enbrel in Children and Adolescents
In a study recently published in The New England Journal of Medicine, a group of investigators led by Amy Paller, M.D., of Northwestern University School of Medicine, found that children and adolescents with moderate to severe plaque psoriasis who received treatment with etanercept (Enbrel) experienced significant improvements in the signs and symptoms of their disease.
Study Method
The 48-week Phase III study was designed to assess the safety and efficacy of Enbrel therapy in children and adolescents between 4 and 17 years old with moderate to severe plaque psoriasis whose disease had been inadequately controlled with topical therapy or who received systemic therapy or phototherapy.
The study involved a total of 211 pediatric, with 106 patients initially randomized to receive 12 once-weekly weight-based doses of Enbrel (0.8 mg/kg up to the intended dose of 50 mg) and 105 patients randomized to receive placebo.
After this double-blind portion, 208 patients entered a 24-week period of open-label Enbrel treatment once-weekly.
At week 36, 138 patients were re-randomized to receive either Enbrel or placebo, to investigate withdrawal and re-treatment.
During the 48-week study, the percentage of patients achieving 75% or greater disease improvement from baseline, as measured by the standard Psoriasis Area and Severity Index (PASI 75), was used to evaluate the efficacy of Enbrel in patients between 4 and 17 years old. The primary efficacy endpoint was PASI 75 at week 12.
Findings
At week 12, which was the conclusion of the double-blind, placebo-controlled portion of the study, 57% (n=60) of pediatric patients treated with Enbrel achieved PASI 75, compared with 11% (n=12) of pediatric patients who received placebo (p<0.001).
At week 36, after 24 weeks of open-label treatment during which all patients in the study received Enbrel, PASI 75 was achieved by 68 percent (n=71) of the patients initially treated with Enbrel from the start of the study and 65 percent (n=67) of those who initially received placebo from the start of the study.
At the end of open-label treatment (week 36), 138 patients were re-randomized to receive either Enbrel or placebo. During this period, patients who lost PASI 75 were re-treated, and no patient had a rebound of psoriasis or a change in their type of psoriasis.
No serious adverse events or serious infections occurred during the 12-week placebo-controlled period, and rates of adverse events were similar for Enbrel and placebo. The most common adverse events observed during the 48-week trial in patients treated with Enbrel were upper respiratory tract infection, headache, and nasopharyngitis.
Paller AS et al for the Etanercept Pediatric Psoriasis Study Group. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med. 2008;358:241-251.
Botox Under Safety Review
The FDA has issued a statement that botulinum toxin A and B are under review following reports of serious adverse events, including 16 deaths.
The review was prompted by a call to action made late last month by the watchdog group Public Citizen saying that the government should place Black Box warnings on Botox (Allergan) and Myobloc (Solstice Neuroscience Inc.). Public Citizen also called for a consumer-friendly guide to be handed out to patients before they undergo treatment.
According to Public Citizen, which reviewed 180 reports submitted to the FDA by the manufacturers of Botox and Myobloc, 16 deaths occurred in patients undergoing treatment with one of the two products. In addition, complications such as difficulty swallowing and aspiration pneumonia, were also reported. Most of the deaths, according to the FDA, were in patients — including some children — who had undergone treatment for cerebral palsy- associated limb spasticity. Use of botulinum toxin for this purpose is unapproved in both children and adults.
In an address given by Public Citizen, according to a release from Allergan, the consumer group had alluded to one death that resulted from Botox Cosmetic. However, no deaths have been linked to the use of Botox Cosmetic, Allergan noted in a company statement. In addition, Allergan maintained that serious adverse events associated with therapeutic use of Botox are rare, and that they are highlighted on the drug’s packaging.
For more information regarding the FDA’s safety review, visit www.fda.gov/medwatch/safety/2008/safety08.htm#botox. /p>
2008 Allergen of the Year: Nickel
By Sharon Jacob, M.D.
This is the first time that nickel has been designated allergen of the year — despite its long reign as the number-one diagnosed allergen in patch-tested populations. The allergen of the year is designated by the American Contact Dermatitis Society based on growing prevalence data and/or novel/impactful exposure sources.
It is alarming that nickel has recently significantly separated itself from the other top allergen contenders. The North American Contact Dermatitis Group reported a positive patch-test prevalence rate to nickel as 10.5% (1985 to 1990), and in the latest data this prevalence has increased to 18.8% (2003 to 2004). Even more disturbing is that a significant number of those affected are children. Children can have the classic presentation of nickel reactions on the earlobes, neck, wrists and infraumbilical area, but there are also non-typical presentations, such as the one Belsito et al coined the “school chair sign”1 on the posterior thighs.
In 1992 the Danish Ministry on Environmental Legislation dictated a maximal allowable release of nickel from personal effects (such as earring posts) and found their sensitization rates dropped from 19% to 5.7%. Following this, the European Union issued a “nickel directive” to effect this same change. We have seen sensitization rates growing in the United States, and it is time for us to also take action, as well.
For more in-depth information about this infamous allergen, see this month’s issue of Dermatitis and refer to the article “Contact Allergen of the Year: Nickel” by Rachel Kornik and Kathryn A. Zug. [chart image]
Dr. Jacob is Assistant Professor of Medicine and Pediatrics (Dermatology) at the University of California, San Diego. She is also the Chair, Public Relations Committee for the American Contact Dermatitis Society.
Reference 1. Samimi SS, Siegfried E, Belsito DV. A diagnostic pearl: the school chair sign. Cutis. 2004 Jul;74(1):27-8.
In Brief…
COLLAGENEX PHARMACEUTICALS INITIATES… Phase II dose finding study of Becocalcidiol for the treatment of psoriasis. The double-blinded, placebo- and active-controlled study will evaluate the safety and efficacy of becocalcidiol using three concentrations of the compound administered once daily versus a vehicle and active control over a 12-week period.
AESTHETIC TECHNOLOGIES ANNOUNCES… An agreement with Cosmetrex partnership to provide microdermabrasion equipment to the cosmetic surgery industry. Under terms of the agreement, Cosmetrex members will have access to Aesthetic Technologies’ Parisian Peel Medical Microdermabrasion equipment, supplies and services through its strategic supply chain.
