Drug Watch

Potential game-changers in the pipeline and newly FDA-approved treatments were highlighted in an overview of new drugs to watch at Maui Derm NP+PA Fall 2021 meeting.

Galderma and Sofregen Medical announced they have entered into an agreement to co-develop a novel line of silk-based biostimulators that will enable immediate volume restoration and provide structure for new tissue generation.

New therapies raise patient expectations for fast efficacy, lower costs, and fewer adverse effects.

Possible melanoma treatments have had multiple newsworthy events since July 2021.

Incyte announced the FDA has approved its topical selective Janus kinase (JAK)1/JAK2 inhibitor ruxolitinib (Opzelura) for the treatment of mild to moderate atopic dermatitis.

In this exclusive video interview, Zoe Diana Draelos, MD, Dermatology Times chief medical editor, weighs in on the recent Black Box Warning issued by the FDA to certain JAK inhibitors.

The FDA has approved halobetasol propionate foam, 0.05% (Lexette; Mayne Pharma), a potent topical corticosteroid, for the treatment of plaque psoriasis in adolescent patients.

The topical HDAC inhibitor remetinostat demonstrated favorable tolerability and clinically significant efficacy in reducing disease burden in patients with basal cell carcinoma, according to results from a phase 2 trial.

Although JAK inhibitors have shown efficacy in treating challenging conditions, federal regulators continue their safety reviews.

The FDA is now requiring black box warning for certain JAK inhibitors used to treat arthritis. This news comes amid delay in FDA approval for multiple JAK inhibitors for the treatment of inflammatory skin conditions.

A phase 3 trial studied the effectiveness of oral abrocitinib along with topical therapy for moderate-to-severe atopic dermatitis in teens.

A recent statement by Regeneron noted that chronic spontaneous urticaria is the fifth disease associated with positive Phase 3 results involving the monoclonal antibody.

The FDA has granted priority review to Merck’s application for pembrolizumab, a treatment for melanoma.

UCB announced that more than 90% of patients treated with bimekizumab have maintained IGA 1/0 results in their long-term BE BRIGHT trial.

The FDA has accepted the New Drug Application (NDA) for tapinarof as a treatment for plaque psoriasis in adults and set the PDUFA target action date to Q2 2022.

Mark Lebwohl, MD, explains the recent delay in approval of JAK inhibitors by the FDA, how it is affecting the inflammatory skin disease community, and if physicians should be concerned.

The FDA has granted priority review to a supplemental biologics license application for pembrolizumab for the use as an adjuvant treatment in adult and pediatric patients with stage IIB or IIC melanoma following complete resection.

The results from the Heads Up study were published in JAMA Dermatology, which demonstrated upadacitinib was superior to dupilumab in treating atopic dermatitis.

Ritlecitinib, an investigational covalent kinase inhibitor, achieved its primary endpoint and demonstrated statistically significant efficacy compared to placebo in treating alopecia areata.

Joshua Zeichner, MD, associate professor of dermatology and director of cosmetic & clinical research in dermatology, Mount Sinai Hospital, New York, discusses the impact of the recent FDA approval of Twyneo (Sol-Gel) for the treatment of acne.

Immunotherapy agent nemvaleukin alfa was granted an FDA fast track designation for the treatment of patient’s mucosal melanoma for previously undergone treatment with an anti-PD-L1 therapy.

MediWound Ltd, announced the results for its CIDS trial studying NexoBrid as a treatment for children with severe thermal burns.

Dalbavancin has received FDA approval to treat acute bacterial skin and skin structure infections in pediatric patients.

The FDA has granted an orphan drug designation to alrizomadlin as a potential therapeutic option for patients with stage IIB-IV melanoma.

The newest FDA indication allows for greater distribution to younger but equally vulnerable immunocompromised patients.

Twyneo, a tretinoin and benzoyl peroxide cream, has been approved by the FDA for the treatment of acne vulgaris in patients 9 years and older.

BFI-751, Biofactura’s biosimilar drug to ustekinumab will be investigated for the first time on human patients.

The combination of belapectin plus pembrolizumab has demonstrated early potential for disease control with acceptable tolerability in patients with metastatic melanoma.

Sol-Gel has announced pre-clinical data on SGT-510, its roflumilast drug, for the treatment of psoriasis.

Journey Medical Corporation and Dr. Reddy’s Laboratories Ltd. have joined forces for the development and commercialization of DFD-19 as a treatment for rosacea.