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LEO seeks FDA approval for aerosol-foam psoriasis treatment
LEO Pharma has submitted a new drug application to the FDA for calcipotriene and betamethasone dipropionate aerosol foam for the treatment of plaque psoriasis. Read to learn more.
LEO Pharma has submitted a new drug application to the Food and Drug Administration for calcipotriene and betamethasone dipropionate aerosol foam for the treatment of plaque psoriasis.
Officials of the Danish company say the first aerosol foam formulation of the fixed combination was developed with the aim of improving treatment for plaque-psoriasis patients.
The FDA submission is based on studies of patients with plaque psoriasis. These include the Phase 3a PSO-FAST study, which evaluated efficacy, safety, itch relief and itch-related sleep loss across a four week period, and the Phase 2 MUSE safety study.
The company says they are planning regulatory filings in Europe and other countries during 2015 and 2016.
