Update on Drugs & Devices: November – December 2022

Trade Name: Sotyktu^™
Company: Bristol Myers Squibb

Approval Dates/Comments: In September 2022, the US FDA approved deucravacitinib, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The approval was based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials, which demonstrated (at both 16 and 24 weeks) superior efficacy of once-daily deucravacitinib compared to placebo and twice-daily apremilast (Otezla^®) in 1,684 patients aged ≥18 years with moderate-to-severe plaque psoriasis. Responses persisted through Week 52, with 82% (187/228) of patients who achieved PASI 75 with deucravacitinib at Week 24 maintaining their response at Week 52 in POETYK PSO-1. In POETYK PSO-2, 80% (119/148) of patients who continued on deukcravacitinib maintained PASI 75 response vs. 31% (47/150) of patients who were withdrawn from deucravacitinib.

Trade Name: Daxxify^™
Company: Revance Therapeutics

Approval Dates/Comments: In September 2022, the FDA approved daxibotulinumtoxinA-lanm for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults. This is the first and only neuromodulator stabilized with Peptide Exchange Technology™ (PXT) and is free of both human serum albumin and animal-based components with the ability to extend the duration of treatment effect compared with commercially available preparations. The median duration of effect was 6 months, with some patients maintaining treatment results at 9 months. Onset of effect is typically seen within 2 days, however results may be visible as early as 1 day after treatment.

Trade Name: Dupixent^®
Company: Regeneron Sanofi-Aventis

Approval Dates/Comments: The FDA approved dupilumab in September 2022 for the treatment of adult patients with prurigo nodularis (PN). This is the first and only drug specifically indicated to treat PN in the US. Regulatory approval was based on data from two Phase 3 trials, PRIME and PRIME2. About three times as many dupilumab-treated patients (60% and 58%) experienced a clinically meaningful reduction in itch from baseline at 24 weeks vs. 18% and 20% for placebo, the primary endpoint in PRIME; 44% and 37% of subjects receiving dupilumab experienced a clinically meaningful reduction in itch from baseline at 12 weeks, vs. 16% and 22% for placebo, the primary endpoint in PRIME2; more than twice as many subjects on dupilumab (48% and 45%) achieved clear or almost clear skin at 24 weeks, vs. 18% and 16% for placebo.

Trade Name: Spevigo^®
Company: Boehringer Ingelheim

Approval Dates/Comments: In September 2022, the FDA approved spesolimab, an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis (GPP) flares in adults, making it the first drug approved for GPP. Regulatory approval was based on data from the Phase 2 EFFISAYIL 1 trial, which reported that spesolimab reached its primary efficacy endpoint in the 12-week trial, with 54% of patients showing no visible pustules after receiving one dose compared with 6% in the placebo arm. Clear or almost clear skin was achieved by 43% of spesolimab-treated patients vs. 11% of placebo.

Trade Name: Koselugo™
Company: AstraZeneca

Approval Dates/Comments: Health Canada approved this inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2) in August 2022 for the treatment of pediatric patients aged ≥2 years with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).