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FDA News
June 2003
Imiquimod for AKs
3M, the manufacturer of imiquimod (Aldara) is seeking FDA approval for use of its drug to treat actinic keratosis. Already approved for treating genital warts, imiquimod has shown promise in treating AKs in clinical trials. In these studies, patients were treated with imiquimod or a placebo cream for 16 weeks. At the
8-week mark, half of patients treated with imiquimod reported 83% reduction in lesions, according to 3M and the Associated Press. The company is hoping to attain approval for this indication of imiquimod within the next year. In addition, 3M reportedly expects to submit new data to the FDA this summer for an additional indication to treat basal cell carcinomas.
Label Update for Soriatane
Acitretin (Soriatane) a staple of psoriasis treatment, has received approval for an enhanced, updated product label from the FDA.
According to Soriatane’s manufacturer, Roche, the major changes include the following:
• amended indication for “severe psoriasis in adults,” changed from previous wording that said “including erythrodermic and pustular.”
• clearer instructions for how to use the drug in combination with phototherapy.
• more rigorous pregnancy testing requirements and warning about birth defects.
• clarified dosing flexibility — with a starting range of 25 mg to 50 mg, rather than 25 mg or 50 mg as
previously stated
• inclusion of efficacy results from trials where the drug showed efficacy in plaque, guttate, palmoplantar, erythrodermic and pustular psoriasis
• addition of a medication guide, which is an easy-to-understand consumer version of the Soriatane label.
New Tube Size for Protopic
Fujisawa has received FDA approval to manufacture a 100-gram tube of tacrolimus ointment (Protopic) in concentrations of 0.03% and 0.1%. The company submitted a supplemental new drug application for the new tube size last December. The new tube sizing of this breakthrough drug became available in May, according to a company statement.
Breakthrough Treatment for Fabry Disease
A new drug for Fabry disease, a condition that can have dermatologic manifestations, such as angio-keratomas and hypohidrosis, was approved by the FDA in May. The drug agalsidase beta (Fabrazyme) is the first ever treatment for this rare and potentially fatal inherited disorder. Fabrazyme is an enzyme replacement therapy that replaces a deficient enzyme in the body that breaks down stored lipids. The drug received orphan status to treat the approximately 5,000 people worldwide affected by this disorder. According to the manufacturer, the drug became available on June 1.
Imiquimod for AKs
3M, the manufacturer of imiquimod (Aldara) is seeking FDA approval for use of its drug to treat actinic keratosis. Already approved for treating genital warts, imiquimod has shown promise in treating AKs in clinical trials. In these studies, patients were treated with imiquimod or a placebo cream for 16 weeks. At the
8-week mark, half of patients treated with imiquimod reported 83% reduction in lesions, according to 3M and the Associated Press. The company is hoping to attain approval for this indication of imiquimod within the next year. In addition, 3M reportedly expects to submit new data to the FDA this summer for an additional indication to treat basal cell carcinomas.
Label Update for Soriatane
Acitretin (Soriatane) a staple of psoriasis treatment, has received approval for an enhanced, updated product label from the FDA.
According to Soriatane’s manufacturer, Roche, the major changes include the following:
• amended indication for “severe psoriasis in adults,” changed from previous wording that said “including erythrodermic and pustular.”
• clearer instructions for how to use the drug in combination with phototherapy.
• more rigorous pregnancy testing requirements and warning about birth defects.
• clarified dosing flexibility — with a starting range of 25 mg to 50 mg, rather than 25 mg or 50 mg as
previously stated
• inclusion of efficacy results from trials where the drug showed efficacy in plaque, guttate, palmoplantar, erythrodermic and pustular psoriasis
• addition of a medication guide, which is an easy-to-understand consumer version of the Soriatane label.
New Tube Size for Protopic
Fujisawa has received FDA approval to manufacture a 100-gram tube of tacrolimus ointment (Protopic) in concentrations of 0.03% and 0.1%. The company submitted a supplemental new drug application for the new tube size last December. The new tube sizing of this breakthrough drug became available in May, according to a company statement.
Breakthrough Treatment for Fabry Disease
A new drug for Fabry disease, a condition that can have dermatologic manifestations, such as angio-keratomas and hypohidrosis, was approved by the FDA in May. The drug agalsidase beta (Fabrazyme) is the first ever treatment for this rare and potentially fatal inherited disorder. Fabrazyme is an enzyme replacement therapy that replaces a deficient enzyme in the body that breaks down stored lipids. The drug received orphan status to treat the approximately 5,000 people worldwide affected by this disorder. According to the manufacturer, the drug became available on June 1.
Imiquimod for AKs
3M, the manufacturer of imiquimod (Aldara) is seeking FDA approval for use of its drug to treat actinic keratosis. Already approved for treating genital warts, imiquimod has shown promise in treating AKs in clinical trials. In these studies, patients were treated with imiquimod or a placebo cream for 16 weeks. At the
8-week mark, half of patients treated with imiquimod reported 83% reduction in lesions, according to 3M and the Associated Press. The company is hoping to attain approval for this indication of imiquimod within the next year. In addition, 3M reportedly expects to submit new data to the FDA this summer for an additional indication to treat basal cell carcinomas.
Label Update for Soriatane
Acitretin (Soriatane) a staple of psoriasis treatment, has received approval for an enhanced, updated product label from the FDA.
According to Soriatane’s manufacturer, Roche, the major changes include the following:
• amended indication for “severe psoriasis in adults,” changed from previous wording that said “including erythrodermic and pustular.”
• clearer instructions for how to use the drug in combination with phototherapy.
• more rigorous pregnancy testing requirements and warning about birth defects.
• clarified dosing flexibility — with a starting range of 25 mg to 50 mg, rather than 25 mg or 50 mg as
previously stated
• inclusion of efficacy results from trials where the drug showed efficacy in plaque, guttate, palmoplantar, erythrodermic and pustular psoriasis
• addition of a medication guide, which is an easy-to-understand consumer version of the Soriatane label.
New Tube Size for Protopic
Fujisawa has received FDA approval to manufacture a 100-gram tube of tacrolimus ointment (Protopic) in concentrations of 0.03% and 0.1%. The company submitted a supplemental new drug application for the new tube size last December. The new tube sizing of this breakthrough drug became available in May, according to a company statement.
Breakthrough Treatment for Fabry Disease
A new drug for Fabry disease, a condition that can have dermatologic manifestations, such as angio-keratomas and hypohidrosis, was approved by the FDA in May. The drug agalsidase beta (Fabrazyme) is the first ever treatment for this rare and potentially fatal inherited disorder. Fabrazyme is an enzyme replacement therapy that replaces a deficient enzyme in the body that breaks down stored lipids. The drug received orphan status to treat the approximately 5,000 people worldwide affected by this disorder. According to the manufacturer, the drug became available on June 1.
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