Leo Pharma has received scientific approval for Enstilar for treatment of psoriasis vulgaris in the EU.
Psoriasis is a chronic, inflammatory skin disease, which is frequently accompanied by multiple physical and psychological comorbidities, such as metabolic syndrome and psoriatic arthritis.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Enstilar is an alcohol-free foam formulation that can now be used for treatment of psoriasis in patients 18 years of age or older in the EU.
Leo Pharma president and CEO Gitte Aabo said: "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."
Approval is based on the safety and efficacy profile from the four week, pivotal Phase 3a PSO-FAST study and Phase II MUSE study.
During clinical trials, patients treated with Enstilar showed significant improvements in symptoms within the first week and more than half achieved treatment success after four weeks.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataApproval leads the way for Enstilar to secure national marketing authorisations by 30 EU countries. National approvals of Enstilar are expected later this year.
In October last year, Enstilar was approved for use by the US Food and Drug Administration (FDA).
More than 2%-4% of the population of western countries suffer from psoriasis. Of this, 80% 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.
