Dermatology

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.

The tools for formulary management for atopic dermatitis need flexibility to take into account quality-of-life issues and patient access.

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.

Genetic testing is playing a growing role in diagnosing and treating diseases, particularly when it comes to certain cancers and rheumatic conditions.

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.

FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

In the beginning of September, FDA released a safety announcement reminding healthcare providers of an increased mortality risk associated with the use of the intravenous antibiotic tigecycline (Tygacil) compared to that of other drugs used to treat similar serious infections.

New biologic: Ustekinumab (Stelara) was approved on September 25, 2009, for the treatment of adult patients aged 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

New molecular entity: Telavancin for injection (Vibativ) was approved on September 11, 2009, for the treatment of complicated skin and skin-structure infections (cSSSIs)

Ustekinumab is a novel investigational human monoclonal antibody (mAb) that is pending approval for the treatment of plaque psoriasis. Subcutaneous administration of ustekinumab has demonstrated efficacy in both phase 2 and 3 trials.