LEO Pharma today announced that it received scientific approval of Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) for the treatment of psoriasis vulgaris in patients 18 years of age or older. Enstilar® is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris.
“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, President and CEO of LEO Pharma. “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.”
Enstilar® was developed to treat patients with psoriasis vulgaris – the most common clinical form of psoriasis. In Europe, nearly four million people are living with psoriasis.
The application in the EU decentralized procedure for Enstilar® was based on the pivotal Phase 3a PSO-FAST study which evaluated the efficacy and safety profile across a four week period, and the Phase 2 MUSE safety profile study. In the PSO-FAST clinical trial, over half of patients treated with Enstilar® were “Clear” or “Almost Clear” by Week 4 as measured by the Investigator Global Assessment (IGA) 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 scientific approval means that LEO Pharma has received a positive outcome of the decentralized procedure. Receiving this positive outcome is the final step before national marketing authorisations can be granted by the 30 EU countries which are part of the procedure. The national approvals of Enstilar® are expected later this year. In October 2015, Enstilar® was approved for use by the U.S. Food and Drug Administration (FDA).