Leo Pharma files for US approval of first aerosol foam for psoriasis
Independent Danish dermatology specialist Leo Pharma has submitted a New Drug Application to the US Food and Drug Administration 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 (also known ex-USA as calcipotriol) and 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 USA 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.
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