Leo Pharma files NDA at FDA for calcipotriene/betamethasone dipropionate aerosol foam for Psoriasis

LEO Pharma announced it has submitted a New Drug Application to the FDA for calcipotriene/betamethasone dipropionate aerosol foam 0,005%/0,064% for the treatment of Psoriasis Vulgaris. The novel aerosol foam formulation of the fixed combination calcipotriene/betamethasone dipropionate has been developed with the aim of improving treatment for patients with Psoriasis Vulgaris, � the most common clinical form of Psoriasis.

The regulatory submission in the US is based on studies of patients with Psoriasis Vulgaris. These include the Phase IIIa PSO-FAST study which evaluated efficacy, safety, itch relief and itch-related sleep loss across a four week period, and the Phase II MUSE safety study. Regulatory filings in Europe and other countries are planned during the course of 2015 and 2016.