Tazarotene lotion, 0.045%
Trade Name: Arazlo™
Company: Bausch Health
Approval Dates/Comments: In August 2021, Health Canada approved tazarotene lotion, 0.045%, for the topical treatment of acne vulgaris in patients ≥10 years of age. This is the first preparation of tazarotene available in a lotion form. It is formulated using Prismatrex™ technology (a novel polymeric emulsification system that may alleviate skin dryness), which has been shown to provide strong efficacy with good tolerability.
Anifrolumab-fnia IV use
Trade Name: Saphnelo™
Company: AstraZeneca
Approval Dates/Comments: The US FDA approved anifrolumab in July 2021 for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. The approval was based on efficacy and safety data from the Saphnelo™ clinical development program, including two TULIP Phase III trials and the MUSE Phase II trial. In these trials, more patients treated with anifrolumab experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid use compared to placebo, with both groups receiving standard therapy. This marks the first regulatory approval for a type I interferon receptor antagonist and the only new treatment approved for SLE in more than 10 years.
Immune globulin intravenous (human) 10%
Trade Name: Octagam® 10%
Company: Octapharma
Approval Dates/Comments: In July 2021, the FDA granted approval to Octagam® 10% (immune globulin intravenous [human]), the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis. Regulatory approval was based on the positive results of the ProDERM study.
Odevixibat capsule
Trade Name: Bylvay™
Company: Albireo Pharma
Approval Dates/Comments: In July 2021, the FDA approved this non-systemic ileal bile acid transport inhibitor for the treatment of pruritus in all subtypes of progressive familial intrahepatic cholestasis. Treatment is administered as a once-daily capsule or opened and sprinkled onto soft foods.
Pembrolizumab IV use
Trade Name: Keytruda®
Company: Merck
Approval Dates/Comments: In July 2021, the FDA expanded the approval for this programmed cell death protein 1 (PD-1) inhibitor to include locally advanced cutaneous squamous cell carcinoma not curable by radiation or surgery.
Tretinoin/benzoyl peroxide cream, 0.1%/3%
Trade Name: Twyneo®
Company: Sol-Gel Technologies
Galderma
Approval Dates/Comments: In July 2021, the FDA approved a fixed-dose combination of a retinoid (tretinoin 0.1%) with an antibacterial agent (benzoyl peroxide [BP] 3%) for the once-daily, topical treatment of acne vulgaris in patients ≥9 years of age. This fixed-drug medication is formulated with a patented technology to entrap tretinoin and BP within silica-based microcapsules to stabilize tretinoin from being degraded by BP and to slowly release both active drugs over time to provide a favorable efficacy and safety profile.
Chlormethine hydrochloride gel
Trade Name: Ledaga™
Company: Recordati Rare Diseases
Approval Dates/Comments: Health Canada approved this antineoplastic agent in June 2021 for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in adult patients who have received prior skin-directed therapy.
HA injectable filler
Trade Name: Restylane® Contour
Company: Galderma
Approval Dates/Comments: The FDA approved this hyaluronic acid (HA)-based dermal filler in June 2021 for cheek augmentation and correction of midface contour deficiencies in adults aged >21 years.
