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LEO Pharma submits NDA for aerosol foam psoriasis treatment

LEO Pharma has submitted a new drug application to the FDA for its novel aerosol foam for the treatment of psoriasis vulgaris, according to a press release.

The foam is a formulation of the fixed combination of 0.005% of calcipotriene and 0.064% betamethasone dipropionate.

The FDA submission is based on the results from studies of patients with psoriasis vulgaris, the most common clinical form of psoriasis, including a phase 3a study that measured efficacy, safety, itch relief and itch-related sleep loss during a 4-week period, as well as a phase 2 safety study, according to the release.

Denmark-based LEO Pharma reported it also plans regulatory filings in Europe and other countries in 2015 and 2016.

Reference: www.leo-pharma.com.