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FDA approves first topical acne treatment in children aged 9 and up
FDA has approved the topical acne drug adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo, Galderma) in children ages 9 and older, according to a news release.
FDA has approved the topical acne drug adapalene 0.1%/benzoyl peroxide 2.5% (Epiduo, Galderma) in children ages 9 and older, according to a news release.
Epiduo had already been approved for acne treatment in children aged 12 years and older. FDA’s more recent approval was based on data from a 12-week, multicenter, randomized, vehicle-controlled, double-blind study of pediatric patients aged 9 to 11 years. The topical treatment was found to be safe and effective, with nearly 70% of patients demonstrating improvement in acne, compared to 23% in patients treated with placebo.
Common side effects reported in the study included dry skin, erythema, skin irritation and discomfort, and a skin burning sensation.
Treating a younger population with acne could help to prevent acne scarring in the future, researchers noted.
FDA Approves Pfizer’s Gene Therapy for Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
