New Indication for Humira
The FDA has granted approval for a new indication for adalimumab (Humira) for the treatment of moderate to severe chronic plaque psoriasis in adults. This treatment is indicated for patients who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
The approval is based on two pivotal trials, REVEAL and CHAMPION. In these studies, nearly 3 in 4 patients achieved 75% clearance or better at week 16 of treatment vs. placebo. Humira has 10 years of clinical trial experience beginning with rheumatoid arthritis patients. It was approved for moderate to severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate to severe Crohn’s disease in 2007.
Orphan Drug for Rare Inflammatory Diseases
The FDA has approved a drug to relieve the symptoms associated with certain chronic inflammatory diseases. Rilonacept (Arcalyst), an Interleukin-1 blocker, received approval for the indication of long-term treatment of two cryopyrin-associated periodic syndromes (CAPS) disorders:
1. Familial cold auto-inflammatory syndrome (FCAS)
2. Muckle-Wells syndrome (MWS).
Symptoms of these disorders include inflammation such as joint pain, rash or skin lesions, fever and chills, eye redness or pain, and fatigue in both children and adults. Muckle-Wells syndrome is associated with more severe inflammation and may include hearing loss or deafness, and some MWS patients may also experience a buildup of a protein substance that damages organs and tissue (amyloidosis). The FCAS and MWS disorders, which are inherited, affect about 300 people in the United States.
Laser Lipolysis Device Cleared
The FDA granted 510(K) clearance to CoolTouch Inc., for its CoolLipo 1320-nm laser system for laser lipolysis. The CoolLipo 1320 laser is designed to ablate fat in areas such as the neck, chin and arms and improves the outcome of conventional liposuction in larger areas such as the abdomen and thighs, according to the company.
In a company statement, Robert Weiss, M.D., F.A.C.P., Associate Clinical Professor of Dermatology at John Hopkins University School of Medicine, indicated that the 1320 wavelength provided excellent skin tightening and fat contouring ability not seen with traditional liposuction alone.
At-Home Hair Removal Device Cleared
The FDA has granted 510(k) clearance for a handheld laser device for at-home hair removal. Known as the TRIA (SpectraGenics, Inc.), the device, which uses a diode laser, is the first hair removal laser to enter the home-based market in the United States, according to the company.
In a company statement, dermatologist Eric Bernstein, M.D., explained that some of his patients use this device for touch-ups in between visits as well as on other areas not treated in-office.
According to SpectraGenics, the company has sold a version of the TRIA, called i-Epi, in Japan since 2005. In addition, the company indicated that the TRIA is the first in a series of at-home science-based beauty devices that it will offer.
TRIA will be available Spring 2008.
At-Home Device for Facial Toning
The NuFace device received clearance from the FDA as an at-home cosmetic device that safely and effectively improves the appearance of the face through the use of microcurrent technology.
NuFace (Carol Cole Company) is a handheld device that utilizes gentle electrical stimulation to life and tone muscles and skin tissue. According to the company, a gentle alternating current is emitted through dual spherical probes as the user glides the device over his or her face.
Clinical studies on microcurrent technology have been conducted by Emil Chi, Ph.D., Director of the University of Washington’s Department of Pathology, according to a company statement. These studies have found that skin tissue treated with microcurrents showed a 45% increase in the number of elastin fibers in the dermis, collagen thickness in connective tissue increased 10%, and the number of blood vessels increased by 35%.
New Indication for Humira
The FDA has granted approval for a new indication for adalimumab (Humira) for the treatment of moderate to severe chronic plaque psoriasis in adults. This treatment is indicated for patients who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
The approval is based on two pivotal trials, REVEAL and CHAMPION. In these studies, nearly 3 in 4 patients achieved 75% clearance or better at week 16 of treatment vs. placebo. Humira has 10 years of clinical trial experience beginning with rheumatoid arthritis patients. It was approved for moderate to severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate to severe Crohn’s disease in 2007.
Orphan Drug for Rare Inflammatory Diseases
The FDA has approved a drug to relieve the symptoms associated with certain chronic inflammatory diseases. Rilonacept (Arcalyst), an Interleukin-1 blocker, received approval for the indication of long-term treatment of two cryopyrin-associated periodic syndromes (CAPS) disorders:
1. Familial cold auto-inflammatory syndrome (FCAS)
2. Muckle-Wells syndrome (MWS).
Symptoms of these disorders include inflammation such as joint pain, rash or skin lesions, fever and chills, eye redness or pain, and fatigue in both children and adults. Muckle-Wells syndrome is associated with more severe inflammation and may include hearing loss or deafness, and some MWS patients may also experience a buildup of a protein substance that damages organs and tissue (amyloidosis). The FCAS and MWS disorders, which are inherited, affect about 300 people in the United States.
Laser Lipolysis Device Cleared
The FDA granted 510(K) clearance to CoolTouch Inc., for its CoolLipo 1320-nm laser system for laser lipolysis. The CoolLipo 1320 laser is designed to ablate fat in areas such as the neck, chin and arms and improves the outcome of conventional liposuction in larger areas such as the abdomen and thighs, according to the company.
In a company statement, Robert Weiss, M.D., F.A.C.P., Associate Clinical Professor of Dermatology at John Hopkins University School of Medicine, indicated that the 1320 wavelength provided excellent skin tightening and fat contouring ability not seen with traditional liposuction alone.
At-Home Hair Removal Device Cleared
The FDA has granted 510(k) clearance for a handheld laser device for at-home hair removal. Known as the TRIA (SpectraGenics, Inc.), the device, which uses a diode laser, is the first hair removal laser to enter the home-based market in the United States, according to the company.
In a company statement, dermatologist Eric Bernstein, M.D., explained that some of his patients use this device for touch-ups in between visits as well as on other areas not treated in-office.
According to SpectraGenics, the company has sold a version of the TRIA, called i-Epi, in Japan since 2005. In addition, the company indicated that the TRIA is the first in a series of at-home science-based beauty devices that it will offer.
TRIA will be available Spring 2008.
At-Home Device for Facial Toning
The NuFace device received clearance from the FDA as an at-home cosmetic device that safely and effectively improves the appearance of the face through the use of microcurrent technology.
NuFace (Carol Cole Company) is a handheld device that utilizes gentle electrical stimulation to life and tone muscles and skin tissue. According to the company, a gentle alternating current is emitted through dual spherical probes as the user glides the device over his or her face.
Clinical studies on microcurrent technology have been conducted by Emil Chi, Ph.D., Director of the University of Washington’s Department of Pathology, according to a company statement. These studies have found that skin tissue treated with microcurrents showed a 45% increase in the number of elastin fibers in the dermis, collagen thickness in connective tissue increased 10%, and the number of blood vessels increased by 35%.
New Indication for Humira
The FDA has granted approval for a new indication for adalimumab (Humira) for the treatment of moderate to severe chronic plaque psoriasis in adults. This treatment is indicated for patients who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
The approval is based on two pivotal trials, REVEAL and CHAMPION. In these studies, nearly 3 in 4 patients achieved 75% clearance or better at week 16 of treatment vs. placebo. Humira has 10 years of clinical trial experience beginning with rheumatoid arthritis patients. It was approved for moderate to severe rheumatoid arthritis in 2002, psoriatic arthritis in 2005, ankylosing spondylitis in 2006, and moderate to severe Crohn’s disease in 2007.
Orphan Drug for Rare Inflammatory Diseases
The FDA has approved a drug to relieve the symptoms associated with certain chronic inflammatory diseases. Rilonacept (Arcalyst), an Interleukin-1 blocker, received approval for the indication of long-term treatment of two cryopyrin-associated periodic syndromes (CAPS) disorders:
1. Familial cold auto-inflammatory syndrome (FCAS)
2. Muckle-Wells syndrome (MWS).
Symptoms of these disorders include inflammation such as joint pain, rash or skin lesions, fever and chills, eye redness or pain, and fatigue in both children and adults. Muckle-Wells syndrome is associated with more severe inflammation and may include hearing loss or deafness, and some MWS patients may also experience a buildup of a protein substance that damages organs and tissue (amyloidosis). The FCAS and MWS disorders, which are inherited, affect about 300 people in the United States.
Laser Lipolysis Device Cleared
The FDA granted 510(K) clearance to CoolTouch Inc., for its CoolLipo 1320-nm laser system for laser lipolysis. The CoolLipo 1320 laser is designed to ablate fat in areas such as the neck, chin and arms and improves the outcome of conventional liposuction in larger areas such as the abdomen and thighs, according to the company.
In a company statement, Robert Weiss, M.D., F.A.C.P., Associate Clinical Professor of Dermatology at John Hopkins University School of Medicine, indicated that the 1320 wavelength provided excellent skin tightening and fat contouring ability not seen with traditional liposuction alone.
At-Home Hair Removal Device Cleared
The FDA has granted 510(k) clearance for a handheld laser device for at-home hair removal. Known as the TRIA (SpectraGenics, Inc.), the device, which uses a diode laser, is the first hair removal laser to enter the home-based market in the United States, according to the company.
In a company statement, dermatologist Eric Bernstein, M.D., explained that some of his patients use this device for touch-ups in between visits as well as on other areas not treated in-office.
According to SpectraGenics, the company has sold a version of the TRIA, called i-Epi, in Japan since 2005. In addition, the company indicated that the TRIA is the first in a series of at-home science-based beauty devices that it will offer.
TRIA will be available Spring 2008.
At-Home Device for Facial Toning
The NuFace device received clearance from the FDA as an at-home cosmetic device that safely and effectively improves the appearance of the face through the use of microcurrent technology.
NuFace (Carol Cole Company) is a handheld device that utilizes gentle electrical stimulation to life and tone muscles and skin tissue. According to the company, a gentle alternating current is emitted through dual spherical probes as the user glides the device over his or her face.
Clinical studies on microcurrent technology have been conducted by Emil Chi, Ph.D., Director of the University of Washington’s Department of Pathology, according to a company statement. These studies have found that skin tissue treated with microcurrents showed a 45% increase in the number of elastin fibers in the dermis, collagen thickness in connective tissue increased 10%, and the number of blood vessels increased by 35%.
