Dermatology

Launched in August, Zoryve is a once-daily, steroid-free cream and is the first topical PDE4 inhibitor approved to treat plaque psoriasis in patients 12 years of age or older.

Dupixent is the first treatment approved to treat prurigo nodularis, a chronic skin disorder characterized by the presence of hard, itchy nodules.

Commercial shipments are already under way of Cosette’s gel formulation of tazarotene to treat patients with acne and facial wrinkles.

Developed by Bristol Myers Squibb, Sotyktu is the first approved TYK2 inhibitor. It is expected to be available later this month.

The FDA is expected to make a decision on Pfizer’s ritlecitinib in the second quarter of 2023.

Daxxify enters the injectable botulinum toxin market as a twice-a year treatment for frown lines.

Spevigo is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling approved to treat for adults with generalized pustular psoriasis flares.

Zoryve is a next-generation topical PDE4 inhibitor to treat adults and adolescents with plaque psoriasis.

Zoryve, the first topical PDE4 inhibitor approved to treat patients with plaque psoriasis, will be available by mid-August.

Opzelura is first therapy approved to treat patients with vitiligo, a disease that causes the loss of skin color.

Piclidenoson is a first-in-class, A3 adenosine receptor agonist small molecule that inhibits the inflammatory cytokines interleukin 17 and 23.

Olumiant is the first systemic therapy available to treat alopecia.

Dupixent is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.

If approved, Dupixent would be the first and only medicine in the United States specifically indicated to treat prurigo nodularis, or persistent itch with thick skin lesions. The PDUFA target action date for the FDA decision is Sept. 30, 2022.

Deficiencies at the contract manufacturing company are, for the second time, holding up approval of VP-102 to treat molluscum contagiosum, a mild skin infection.

Vtama is approved to treat adults with mild, moderate, and severe psoriasis. It is expected to be available in the first week of June 2022.

Bimekizumab, now called Bimzelx, is a monoclonal antibody being reviewed as treatment for adults with moderate-to-severe plaque psoriasis.

The study aims to generate data related to Tremfya in people of color who have plaque psoriasis.

Opzelura is being reviewed as a treatment for vitiligo, a disease that causes the loss of skin color. The new PDUFA date is July 18, 2022.

Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.

The FDA has assigned a Prescription Drug User Fee Act goal date of Sept. 10, 2022, for deucravacitinib. If approved, it would be the first TYK2 inhibitor approved for the treatment of any disease.

COVID-19 travel restrictions have hindered the FDA’s ability to inspect European manufacturing facilities for bimekizumab, which is under review for the treatment of patients with psoriasis.

Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.

ICER’s policy recommendations suggest payers establish step therapy with less expensive systemic agents to allow patients and clinicians to choose from multiple options.

The single-dose antibiotic with a one-hour infusion is approved to treat MRSA and other skin infections.

FDA has approved dabrafenib (Tafinlar, GlaxoSmithKline) and trametinib (Mekinist, GlaxoSmithKline) for patients with advanced (metastatic) or unresectable melanoma.

Actavis Inc. announced May 20 its plans to acquire Warner Chilcott in a stock transaction deal, which is worth approximately $8.5 billion. The merger is expected to create a global specialty pharmaceutical company serving the women’s health, gastroenterology, urology, and dermatology therapeutic sectors, according to a joint company 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.

The FDA has released a safety communication alerting healthcare providers to a new risk evaluation and mitigation strategy for ipilimumab.

FDA has approved peginterferon alfa-2b (Sylatron, Merck) for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.