Roflumilast cream 0.3%
Trade Name: Zoryve™
Company: Arcutis Biotherapeutics
Approval Dates/Comments: Health Canada approved the first topical phosphodiesterase-4 inhibitor in April 2023 as a once-daily, non-steroidal therapy for mild, moderate and severe plaque psoriasis, including treatment of psoriasis in the intertriginous areas, in patients ≥12 years of age. In two clinical trials, DERMIS-1 and DERMIS-2, roflumilast cream achieved investigator-assessed treatment success in over 40% of patients at week 8 compared with vehicle. This drug gained US FDA approval in July 2022.
Adalimumab-aaty SC use
Trade Name: Yuflyma®
Company: Celltrion
Approval Dates/Comments: In May 2023, the FDA approved adalimumab-aaty, a high-concentration (100 mg/mL) and citrate-free biosimilar to adalimumab (Humira®) to treat 8 conditions, including psoriatic arthritis, plaque psoriasis and hidradenitis suppurativa.
Beremagene geperpavec-svdt topical gene therapy
Trade Name: Vyjuvek™
Company: Krystal Biotech
Approval Dates/Comments: In May 2023, the first and only topical gene therapy was approved by the FDA to treat dystrophic epidermolysis bullosa in patients ≥6 months of age. Vyjuvek™ is a herpes-simplex virus type 1 vector-based gene therapy that addresses the underlying genetic cause of the disease by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional COL7 protein expression with redosing.
Molecular imaging device
Trade Name: Orlucent® Skin Fluorescence Imaging System
Company: Orlucent, Inc.
Approval Dates/Comments: The FDA granted Breakthrough Device designation to the Orlucent® system in May 2023. This handheld point-of-care molecular-based imaging system is designed to non-invasively identify and clinically assess the presence of biological tissue remodeling activity associated with the development of atypical moles in adults. In conjunction with visual skin examination, this device aids physicians to determine clinical decisions and identify the earliest stages of melanoma.
Tirbanibulin ointment 1% w/w
Trade Name: Onakta™
Company: Avir Pharma
Approval Dates/Comments: In May 2023, Health Canada approved a new topical microtubule inhibitor indicated for the field treatment of nonhyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) on the face or scalp in adults. Tirbanibulin ointment should be applied to the affected area on the face or scalp (up to 25 cm2) once-daily for 1 treatment cycle of 5 consecutive days using 1 single-dose sachet per application. FDA approval was gained in December 2020 (trade name: Klisyri®).
Pegunigalsidase alfa-iwxj for IV use
Trade Name: Elfabrio®
Company: Chiesi Global Rare Diseases
Approval Dates/Comments: The FDA approved pegunigalsidase alfa-iwxj, a PEGylated enzyme replacement therapy, in May 2023 for the treatment of adult patients with Fabry disease. As Fabry disease is caused by deficiency of the lysosomal enzyme α–Galactosidase–A, this treatment provides an exogenous source.
Autologous cell harvesting device
Trade Name: Recell® System
Company: Avita Medical
Approval Dates/Comments: In June 2023, the FDA granted premarket approval to the Recell® System for the treatment of vitiligo. This is a one-time treatment at the point-of-care, whereby a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
Odevixibat capsules/pellets
Trade Name: Bylvay®
Company: Ipsen
Approval Dates/Comments: The FDA expanded the approved uses of oral odevixibat in June 2023 to include treatment of cholestatic pruritus in patients ≥12 months of age with Alagille syndrome. Odevixibat is a once-daily, non-systemic ileal bile acid transport inhibitor that acts locally in the small intestine and has minimal systemic exposure.
