Health Canada has granted approval to Arcutis Biotherapeutics’ Zoryve (roflumilast) cream 0.3% to treat people aged 12 years and above with Plaque Psoriasis.
The next generation topical phosphodiesterase-4 (PDE4) inhibitor Zoryve is also indicated to treat psoriasis in the intertriginous areas.
It uses a drug delivery formulation, HydroARQ Technology, which creates a non-greasy moisturising cream that easily spreads and absorbs quickly.
This approval marks the first topical PDE4 inhibitor to receive approval outside of the US.
Insomnia, upper respiratory tract infection, headache, application site pain, urinary tract infection, nausea, and diarrhea are the most common adverse reactions.
Arcutis Biotherapeutics president and CEO Frank Watanabe said: “The successful approval of Zoryve in Canada is a testament to Arcutis’ continued commitment to provide therapies that address the most persistent challenges for individuals with immune-mediated skin diseases.
“We are proud to bring this important new steroid-free cream to Canada, where there is a need for safe and effective topical treatment for plaque psoriasis.
“We deeply value our ongoing partnership with Canadian dermatologists, who played a central role in the development of Zoryve, providing approximately one-third of all clinical trials participants, and we look forward to continuing to advance our robust pipeline in both Canada and the United States.”
In July last year, the US Food and Drug Administration (FDA) approved Zoryve New Drug Application (NDA) for the same indication.