Trade Name: Sotyktu™
Company: Bristol Myers Squibb Canada
Approval Dates/Comments: In November 2022, Health Canada approved oral deucravacitinib, a first-in-class treatment for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Deucravacitinib is a tyrosine kinase 2 (TYK2) inhibitor that works by selectively blocking the activity of the TYK2 enzyme, which is involved in the inflammatory process. Approval was based on data from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials. These 52-week trials investigated the safety and efficacy of once-daily deucravacitinib vs. placebo and oral apremilast (Otezla®) in 1,684 patients aged ≥18 years. The percentage of patients achieving Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment score of 0 or 1 (sPGA 0/1) at week 16 vs. placebo were the co-primary endpoints of the trials. Additionally, the percentage of subjects who achieved PASI 75, PASI 90 and sPGA 0/1 vs. apremilast at weeks 16 and 24 were the key secondary endpoints. Findings from the Phase 3 trials demonstrated that deucravacitinib was efficacious through 52 weeks. Additionally, clinical responses were maintained in patients who received continuous deucravacitinib therapy and were improved in those who switched from placebo at week 16 to deucravacitinib.
mRNA vaccine + pembrolizumab IV combination therapy
Trade Name: mRNA-4157/V940 + Keytruda®
Company: Moderna/Merck & Co.
Approval Dates/Comments: In December 2022, positive data was announce regarding the Phase 2b KEYNOTE-942 trial, which investigated a novel messenger RNA (mRNA) vaccine (known as mRNA-4157/V940), in melanoma patients. The combination of mRNA-4157/V940 (a personalized cancer vaccine) and pembrolizumab (anti-programmed cell death protein 1 treatment), was administered as an adjuvant therapy following complete tumor resection in Stage III/IV melanoma patients. This adjuvant combination therapy reduced the risk of recurrence or death by 44% compared with pembrolizumab monotherapy.
Adalimumab-aacf SC injection
Trade Name: Idacio®
Company: Fresenius Kabi
Approval Dates/Comments: The US FDA approved this citrate-free adalimumab biosimilar in December 2022 for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira®, including plaque psoriasis and psoriatic arthritis.
Dupilumab for SC injection
Trade Name: Dupixent®
Approval Dates/Comments: In December 2022, the European Commission (EC) expanded the marketing authorization for dupilumab in the European Union to treat adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy. With this approval, dupilumab is the first and only targeted medicine specifically indicated to treat PN in Europe and the US.
Spesolimab IV injection
Trade Name: Spevigo®
Company: Boehringer Ingelheim
Approval Dates/Comments: The EC granted a conditional marketing authorization in December 2022 for spesolimab, as a first-in-class treatment for generalized pustular psoriasis (GPP) flares in adults. Spesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor, a signalling pathway in the immune system that is involved in the pathogenesis of many autoinflammatory diseases, including GPP.