LEO Pharma Submits NDA for Aerosol Foam for Psoriasis to FDA

January 5, 2015

LEO Pharma has submitted a New Drug Application to 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, according to the company.

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. This latest submission, LEO Pharma says, reinforces the company’s strong commitment to dermatology.

 

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