Health Canada to review roflumilast cream new drug submission

Health Canada has accepted a new drug submission for roflumilast cream 0.3% for the treatment of plaque psoriasis, Arcutis Biotherapeutics announced in a press release.

A once-daily roflumilast formulation, ARQ-151 is a phosphodiesterase type 4 (PDE4) inhibitor.

The NDA submission and review approval are based on results of the DERMIS-1 and DERMIS-2 randomized, parallel, double-blind, vehicle controlled, multicenter studies.

An IGA success rate of 42.4% and 37.5% was achieved by roflumilast-treated patients, respectively, compared with 6.1% and 6.9% of those treated with vehicle.

“The acceptance for review of our [new drug submission] by Health Canada marks an important milestone not only for Arcutis but for the approximately 1 million Canadians living with plaque psoriasis who currently have limited options when it comes to topical treatments. Canadian dermatologists and their patients have played a critical role in our roflumilast clinical development program with one in four patients in our DERMIS trials enrolled in Canadian sites, so we look forward to providing topical roflumilast to them, if approved,” Frank Watanabe, president and CEO of Arcutis, said in the release.

A target action date has been set for April 30, 2023.