Leo Pharma gets EU scientific approval for its psoriasis drug Enstilar
pharmafile | March 21, 2016 | News story | Business Services, Research and Development, Sales and Marketing | EU, Enstilar, LEO Pharma, psoriasis vulgaris
Leo Pharma on Monday said its drug to treat inflammatory skin condition has received scientific approval in the European Union.
The regulatory nod is the final step before national marketing authorisations can be granted for the drug in the EU. Enstilar (calcipotriol/betamethasone dipropionate) is an alcohol-free foam formulation for the topical treatment for psoriasis vulgaris, the company said in a statement.
Gitte Aabo, chief executive of Leo Pharma, says: “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.
The application in the EU decentralized procedure for Enstilar was based on a Phase III and Phase II study evaluating the efficacy and safety profile of the drug. Trials showed over half of patients treated with Enstilar were “Clear” or “Almost Clear” by Week 4. Additionally, more than half of patients treated with Enstilar achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline.
The national approvals of Enstilar are expected later this year. In October 2015, Enstilar was approved for use by the US Food and Drug Administration (FDA).
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. About 80% of patients are affected by psoriasis vulgaris – the most common type of psoriasis.
Anjali Shukla
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