LEO Pharma’s Enstilar has won scientific approval in Europe for the treatment of psoriasis vulgaris in adults, pushing it closer to marketing clearance.
The move marks the final step before national marketing authorisations can be granted by the 30 countries part of the European Union’s decentralized procedure.
National approvals of Enstilar are expected later this year, which will make it the first fixed combination topical foam treatment for people living with psoriasis vulgaris in the region, according to LEO.
“The scientific approval of Enstilar is exciting news, not only for LEO Pharma but also for the millions of Europeans living with psoriasis,” said Gitte Aabo, the firm’s president and chief executive. “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.”
The application was based on data from the pivotal Phase IIIa PSO-FAST study, in which over half of half of patients treated with Enstilar were considered “Clear” or “Almost Clear” by week 4 of treatment, as measured by the Investigator Global Assessment improvement score.
Additionally, more than half of patients treated with Enstilar achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline, the LEO noted.
The treatment was approved by the US Food and Drug Administration in October last year.