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




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

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

You may recognize roflumilast as the active ingredient in AstraZeneca’s COPD medicine Daliresp. PDE4s have long been used to treat skin and other inflammatory conditions, with Otezla being one of the most notable. However, previous generations have burdensome side effects, most commonly nausea, diarrhea and vomiting that “really limited the usefulness of PDE4s,”[ads1]; said CEO Frank Watanabe.

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

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