Enstilar receives scientific approval in EU for treating psoriasis

LEO Pharma announced in a press release that Enstilar has received scientific approval in the E.U. for treating psoriasis vulgaris in adults aged 18 years and older.

Enstilar (calcipotriol/betamethasone dipropionate, 50 µg/g and 0.5 mg/g, respectively) is an alcohol-free, fixed-combination topical foam treatment for psoriasis vulgaris, which received FDA approval in October 2015.

The scientific approval is the final step before marketing authorizations can be granted by the 30 E.U. countries which are part of the procedure. National approvals are expected later this year, LEO Pharma reported. Marketing approval would make Enstilar the first fixed combination topical foam treatment for people living with psoriasis in the E.U., according to the release.

“The scientific approval of Enstilar is exciting news, not only for LEO Pharma but also for the millions of Europeans living with psoriasis,” Gitte Aabo, president and CEO of LEO Pharma, stated in the release. “Enstilar is a first-of-its-kind topical spray foam and we believe it will help people living with psoriasis by providing a new type of treatment option that they are looking for.

Results of a phase 3a study and phase 2 study were used for the application for the E.U. decentralized procedure. In the phase 3 study, more than half the patients treated with Enstilar were “clear” or “almost clear” by week 4, according to Investigator Global Assessment improvement score. More than half the patients also achieved a 75% improvement in Psoriasis Area and Severity Index score from baseline, according to the release.

Reference: www.leopharma.com