Drug Watch

Explore the dermatologic drugs the FDA will make a decision to approve during April 2021.

The FDA has approved cemiplimab-rwlc as the first immunotherapy for use in patients with advanced basal cell carcinoma that has previously been treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate.

ZILXI (FMX103, VYNE Therapeutics), a 1.5% topical minocycline foam, is now available for prescription for the treatment of inflammatory lesions of rosacea in adult patients.

UCB announces the U.S. Food and Drug Administration and the European Medicines Agency have accepted the Biologics License Application and Marketing Authorization Application for bimekizumab for the treatment of moderate-to-severe plaque psoriasis in adults.

Merck announces positive results from its phase 2b trial evaluating sonelokinab, an investigational anti-IL-17 A/F nanobody, in adult patients with moderate-to-severe chronic plaque psoriasis.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for Sol-Gel’s Epsolay, a 5% microencapsulated benzoyl peroxide cream for the treatment of inflammatory lesions of rosacea or papulopustular rosacea.

Novartis announces their phase 3 study investigating spartalizumab (PDR001) in combination with dabrafenib (Tafinlar) and trametinib (Mekinist) failed to meet its primary endpoint.

MC2 Therapeutics and EPI Health announce they have entered into a collaboration agreement for the commercialization of calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064% (Wynzora Cream), a newly U.S. FDA-approved topical treatment for plaque psoriasis in adults.

Alembic Pharmaceuticals announces the launch of their bioequivalent and therapeutically equivalent product to Differin Gel 0.3% (Galderma), Adapalene Gel USP 0.3%, a topical retinoid for the treatment of acne vulgaris in patients 12 years and older.

Clascoterone cream 1% (Winlevi, Cassiopea), a first-in-class androgen receptor inhibitor, has been approved by the U.S. FDA for treatment of acne vulgaris in patients 12 years and older.

Eli Lilly’s mirikizumab demonstrates superiority over secukinumab (Cosentyx, Novartis) as a treatment for moderate-to-severe plaque psoriasis, according to recently released results from the OASIS-2 study.

The U.S. Food and Drug Administration has approved IL-12/IL-23 inhibitor ustekinumab (Stelara, Janssen Pharmaceutical Companies of Johnson & Johnson) for treatment of moderate-to-severe plaque psoriasis in pediatric patients 6-11 years.

Researchers have identified and developed lists of medications that may not function properly due to concomitant cannabinoid use in an effort to help medical professionals prescribe prescription drugs safely to their patients.

The U.S. Food and Drug Administration (FDA) has granted JAK-inhibitor delgocitinib cream (LEO Pharma) Fast Track Designation for chronic hand eczema.

The European Commission has approved secukinumab (Cosentyx, Novartis) for treatment of moderate-to-severe plaque psoriasis in pediatric patients 6<18 years in the European Union.

The U.S. Food and Drug Administration has approved atezolizumab plus cobimetinib and vemurafenib for treatment of BRAF V600 mutation-positive advanced melanoma. Studies show the combination treatment prolonged patients’ lives by 15 months without disease worsening.

A recently published pooled 10-year analysis shows pembrolizumab demonstrates long-term survival benefits for advanced melanoma patients regardless of BRAF V600E/K mutation status or history of BRAFi, with or without MEKi therapy.

The U.S. Food and Drug Administration has approved Wynzora Cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%, MC2 Therapeutics) for adult with plaque psoriasis. Wynzora is equipped with the MC2 Therapeutics’ patented PAD Technology and is currently under review in the EU.

Guselkumab becomes the first IL-23 inhibitor approved for treatment of psoriatic arthritis by the U.S. Food and Drug Administration (FDA) following positive phase 3 results from two trials investigating the safety and efficacy of the drug.

The U.S. Food and Drug Administration has approved Mylan and Fujifilm Kyowa Kirin Biologics’ adalimumab-fkjp as a biosimilar to AbbVie’s adalimumab for a variety of inflammatory disease including plaque psoriasis and psoriatic arthritis.

The U.S. Food and Drug administration has accepted the Biologics License Application for tralokinumab (LEO Pharma) for moderate-to-severe atopic dermatitis and is expected to make a decision in the second quarter of 2021.

The U.S. FDA has approved collagenase clostridium histolyticum-aaes (Qwo, Endo International), making it the first FDA-approved injectable treatment for moderate-to-severe cellulite in the buttocks in adult women.

The U.S. Food and Drug Administration has approved a single-dose 300 mg pre-filled pen version of dupilumab (Dupixent, Sanofi and Regeneron) for the treatment of atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP) in U.S. patients 12 years and older.

Almirall announces the U.S. Food and Drug Administration has approved the updated label for their oral antibiotic sarecycline (Seysara) for treatment of acne vulgaris to help promote the appropriate use of the drug to aid in preventing antimicrobial resistance commonly warned when using antibiotics

ICYMI, this week’s edition features a video series on social media use in dermatology, the launch of our new podcast, as well as articles about FDA approvals for acne and cSCC, progress in epidermolysis bullosa, new rosacea management treatment, plus more.