LEO Pharma A/S announces regulatory submission of ENSTILAR® for psoriasis in Europe

ENSTILAR® has the potential to be the first cutaneous foam approved for the treatment of psoriasis vulgaris.

LEO Pharma A/S today announced it submitted a Marketing Authorisation Application for Enstilar^® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) cutaneous foam for the treatment of psoriasis vulgaris, a chronic, inflammatory skin disease that can significantly impact quality of life for patients to 30 European health authorities.

The new cutaneous foam formulation is a fixed combination of calcipotriol and betamethasone (as dipropionate) developed with the aim of improving treatment for patients with psoriasis vulgaris – the most common form of psoriasis.

The European submission is based on the phase 3a trial, the PSO-FAST trial, which evaluated the efficacy, safety, itch relief and improvement of itch-related sleep loss across a four week period with Enstilar^® as well as the phase 2 maximum use systemic exposure safety study of Enstilar^®.

Kim Kjøller, Senior Vice President, Global Development at LEO Pharma, commented:

We believe Enstilar^® has the potential to provide a new, topical treatment option for patients living with psoriasis.  Helping people suffering from skin conditions is at the heart of what we do and this regulatory submission, along with our existing treatment portfolio and patient support offerings such as QualityCare^TM, reinforces our commitment and takes another step toward improving quality of life for people living with psoriasis.

In December 2014, a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) for Enstilar^®