Sarepta plans to file for accelerated Duchenne approval, with adcomm a ‘near certainty’ – Endpoints News

Make way, Dermavant. Two months after the company vowed to upend the plaque psoriasis market with its newly approved vanishing cream, there’s another topical to contend with.

Arcutis Biotherapeutics secured a win on Friday for its phosphodiesterase-4 (PDE4) inhibitor roflumilast, now marketed as Zoryve in plaque psoriasis for children and adults ages 12 and up.

You may recognize roflumilast as the active ingredient in AstraZeneca’s COPD drug Daliresp. PDE4s have long been used to treat skin and other inflammatory conditions, with Otezla being one of the most notable. However, earlier generations carry burdensome side effects, most commonly nausea, diarrhea and vomiting that “really limited the usefulness of PDE4s,” CEO Frank Watanabe said.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 146,700+ biopharma pros reading Endpoints daily — and it’s free.

Leave a Comment

Your email address will not be published.

%d bloggers like this: