LEO Pharma gets scientific approval of Enstilar to treat Psoriasis in EU

Enstilar is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris.

LEO Pharma president and CEO Gitte Aabo said: "The scientific approval of Enstilar is exciting news, not only for LEO Pharma but also for the millions of Europeans living with psoriasis.

"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,5 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).

About Enstilar

Enstilar is a novel topical spray foam treatment for psoriasis that is designed to provide patients with a convenient treatment option that can be easily applied. In clinical trials, Enstilar was well-tolerated and provided fast relief from psoriasis symptoms.

Patients treated with Enstilar in clinical trials experienced significant improvements in symptoms within the first week and more than half achieved treatment success after four weeks.

About Psoriasis

Psoriasis is a chronic, inflammatory skin disease, which is frequently accompanied by multiple physical and/or psychological comorbidities, such as metabolic syndrome and psoriatic arthritis.

Psoriasis is estimated to affect about 2-4% of the population in western countries. 80% of patients are affected by psoriasis vulgaris – the most common type of psoriasis.

Topical treatments can be used as first-line therapies for the majority of patients suffering from psoriasis.