Gene therapy for DEB

Trade Name: AGLE-102
Company: Aegle Therapeutics
Approval Dates/Comments: In October 2020, the US FDA granted Fast Track designation to AGLE-102 for the topical treatment of dystrophic epidermolysis bullosa, a rare genetic pediatric skin blistering disorder. AGLE-102 is an extracellular vesicle therapy that delivers proteins, genetic material and regenerative healing factors to diseased and damaged tissue.

Golimumab for IV use

Trade Name: Simponi® Aria™
Company: Janssen Pharmaceutical

Approval Dates/Comments: In September 2020, the FDA approved golimumab (a TNF blocker) for treating patients ≥2 years of age with active polyarticular juvenile idiopathic arthritis, and has expanded the active psoriatic arthritis (PsA) indication to include this patient population. Previously, the treatment was indicated for active PsA in patients aged ≥18 years.

Clascoterone 1% cream

Trade Name: Winlevi®
Company: Cassiopea SpA

Approval Dates/Comments: In August 2020, the FDA approved clascoterone (cortexolone 17α-propionate) 1% cream for treating acne vulgaris in patients aged ≥12 years. This is the first acne drug with a new mechanism of action to gain regulatory approval in the US in the last 40 years. Clascoterone is a topical androgen receptor inhibitor that limits lipid production from sebocytes and reduces proinflammatory cytokines, mediators influenced by androgens.

Triplet melanoma therapy

Trade Name: Tecentriq® + Cotellic® and Zelboraf®
Company: Genentech

Approval Dates/Comments: In August, 2020, the FDA approved the triplet regimen of atezolizumab (Tecentriq®, anti-PD-L1 antibody) + cobimetinib (Cotellic®, MEK inhibitor) and vemurafenib (Zelboraf®, BRAF kinase inhibitor) for treating BRAF V600 mutation-positive advanced melanoma patients. This is the first FDA-approved combination for metastatic melanoma that brings together immunotherapy with targeted therapies.

Ustekinumab for SC use

Trade Name: Stelara®
Company: Janssen Pharmaceutical

Approval Dates/Comments: The FDA approved an expanded indication for ustekinumab, an interleukin (IL)-12 and IL-23 inhibitor, in July 2020 for the treatment of pediatric patients (6-11 years of age) with moderate to severe plaque psoriasis.

Calcipotriene + betamethasone dipropionate cream

Trade Name: Wynzora®
Company: MC2 Therapeutics

Approval Dates/Comments: The FDA approved this first cream-based fixed dose combination of calcipotriene + betamethasone dipropionate, w/w 0.005%/0.064%, in July 2020 for the once-daily topical treatment of plaque psoriasis in adults aged ≥18 years.

Abametapir 0.74% lotion

Trade Name: Xeglyze™
Company: Dr. Reddy’s Laboratories

Approval Dates/Comments: In July 2020, the FDA approved abametapir lotion for the topical treatment of head lice infestation in patients ≥6 months of age. Abametapir is a novel pediculicide that works by inhibiting metalloproteinases, which play a role in physiological processes crucial for egg development and survival of lice.

Sonidegib capsules

Trade Name: Odomzo®
Company: Sun Pharma

Approval Dates/Comments: Health Canada approved this oral antineoplastic agent (a hedgehog pathway inhibitor) in June 2020 for treating adult patients with histologically confirmed locally advanced basal cell carcinoma that is not amenable to radiation therapy or curative surgery.

Halobetasol propionate + tazarotene lotion

Trade Name: Duobrii™
Company: Bausch Health
Approval Dates/Comments: In June 2020, Health Canada approved a new combination formulation corticosteroid/retinoid (0.01% w/w halobetasol propionate and 0.045% w/w tazarotene) lotion, indicated for improving the signs and symptoms of plaque psoriasis in adult patients with moderate to severe plaque psoriasis.

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