LEO Pharma submits NDA to US FDA for aerosol foam to treat plaque psoriasis

PBR Staff Writer Published 06 January 2015

LEO Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for calcipotriene and betamethasone dipropionate aerosol foam to treat patients with plaque psoriasis, the most common clinical form of psoriasis.

The aerosol foam formulation of the fixed combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, has been developed to improve treatment for patients with plaque psoriasis.

The NDA is based on studies of patients with plaque psoriasis, which include the Phase IIIa PSO-FAST trial that evaluated efficacy and safety at four weeks and the Phase II MUSE safety trial.

LEO Pharma president and CEO Barbara Osborne said: "Psoriasis is a chronic, debilitating disease. Patients with inadequately managed plaque psoriasis can experience substantial burden of illness, with similar reductions in quality of life to those experienced by patients with diabetes or cancer.

"With the regulatory submission announced today, we are taking a step further towards providing additional topical treatment options for people living with psoriasis."

The company said that regulatory filings in Europe and other countries are planned during the course of 2015 and 2016.

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LEO Pharma submits NDA to US FDA for aerosol foam to treat plaque psoriasis