LEO Pharma announces it has submitted a New Drug Application (NDA) for calcipotriene and betamethasone dipropionate aerosol foam, 0.005%/0.064%, to the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis.
The first aerosol foam formulation of the fixed combination calcipotriene/betamethasone dipropionate has been developed with the aim of improving treatment for patients with plaque psoriasis - the most common clinical form of psoriasis.
The regulatory submission in the US is based on studies of patients with plaque psoriasis. These include the Phase 3a PSO-FAST study which evaluated efficacy and safety at four weeks[1] and the Phase 2 MUSE safety study.[2]
Barbara J. Osborne, President and CEO, commented:
"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."
Regulatory filings in Europe and other countries are planned during the course of 2015 and 2016.
With this latest submission, LEO Pharma demonstrates a strong commitment to dermatology.
At-home phototherapy proves effective for psoriasis treatment