Recent FDA actions in dermatology include psoriasis, nasolabial fold treatments

Recent FDA actions have included approving Juvéderm Vollure XC for treating nasolabial folds with results up to 18 months and the addition of fingernail psoriasis data to Humira prescribing information.

Other actions reported in Healio.com/Dermatology have included the FDA’s approval of Dupixent injection to treat adults with moderate-to-severe atopic dermatitis:

FDA approves Juvéderm Vollure XC for treating nasolabial folds with results up to 18 months

The FDA has approved marketing Juvéderm Vollure XC for correcting moderate-to-severe wrinkles and folds, such as nasolabial folds, in adults aged 21 years and older, according to a news release from Allergan.

In a clinical U.S. trial, a majority (59%) of people treated with Juvéderm Vollure XC, which is formulated with Allergan’s proprietary Vycross technology that blends different molecular weights of hyaluronic acid, had improvement of moderate-to-severe nasolabial folds up to 18 months, according to the release. With Perspectives. Read more

FDA approves adding fingernail psoriasis data to Humira prescribing information

The FDA has approved including moderate-to-severe fingernail psoriasis data in the Humira prescribing information for patients with moderate-to-severe plaque psoriasis, AbbVie has reported.

Humira (adalimumab, AbbVie) is the first biologic treatment with data on fingernail psoriasis in its U.S. prescribing information, according to a news release from AbbVie. Read more

FDA approves Dupixent for atopic dermatitis

The FDA has approved Dupixent injection to treat adults with moderate-to-severe atopic dermatitis whose disease in not adequately controlled with topical therapies or when those therapies are not advisable.

Dupixent (dupilumab, Regeneron Pharmaceuticals and Sanofi) is the first biologic medicine approved for this indication, according to a press release from Regeneron and Sanofi. It can be used with or without topical corticosteroids. With Perspective. Read more

FDA grants breakthrough therapy designation to Rituxan for pemphigus vulgaris

The FDA has granted breakthrough therapy designation status to Rituxan for treating pemphigus vulgaris, Genentech has announced.

Pemphigus vulgaris is a rare autoimmune, intraepidermal blistering disease of the skin and mucous membranes that can be life-threatening, and is estimated that three in every 100,000 people are diagnosed with the disease, according to a press release from Genentech. Read more

FDA approves Bavencio for metastatic Merkel cell carcinoma

The FDA granted accelerated approval to avelumab for the treatment of patients aged 12 years and older with metastatic Merkel cell carcinoma.

The approval of avelumab (Bavencio; EMD Serono, Pfizer) includes use of the agent among patients who have not received chemotherapy. Read more