LEO Pharma, an independent, research-based pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Enstilar (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) foam for the treatment of psoriasis vulgaris in patients 18 years of age or older in the United States. Enstilar is a once-daily, alcohol-free topical treatment.
“We are very pleased by the US approval of Enstilar and believe it will provide patients with the type of treatment option that they are looking for,” said Gitte Aabo, president and CEO of LEO Pharma.
“At LEO Pharma, we are committed to providing patients with innovative, new solutions and we believe the foam formulation of Enstilar can help patients living with psoriasis.”
Enstilar was developed to treat patients with psoriasis vulgaris – the most common clinical form of psoriasis.
The US approval of Enstilar was based on the 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 pivotal phase 3 PSO-FAST clinical trial, over half of patients treated with Enstilar were clear or almost clear by week 4 as measured by the 2-step Investigator Global Assessment (IGA) improvement score. Additionally, more than half of patients treated with Enstilar achieved a 75 per cent improvement in Psoriasis Area and Severity Index (PASI) score from baseline.
In March 2015, LEO Pharma submitted Marketing Authorisation Applications to 30 European Health Authorities for Enstilar, however, the product is currently only approved for use in the US.
Enstilar combines a vitamin D analogue (calcipotriol) with a potent corticosteroid (betamethasone dipropionate) to achieve a normalizing result on the affected skin cells and promote a greater anti-inflammatory response than the monotherapy components alone in patients suffering from psoriasis vulgaris.
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 per cent of the population in western countries.8 80 per cent 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.