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Leo Pharma’s Enstilar approved by FDA

Topical psoriasistreatment given the green light
FDA

The FDA has approved Leo Pharma's Enstilar foam for the treatment of plaque psoriasis.

The approval comes on the back of a clinical trial that showed patients achieved significant degrees of improvement after only two weeks of use.

In the phase III trial, over half of patients treated with Enstillar were 'clear' or 'almost clear' by week four as assessed by the investigator global assessment (IGA) score of disease severity. Additionally, more than half of patients treated with Enstillar achieved a 75% improvement in psoriasis and severity index (PASI).

Barbara Osborne, president and CEO of Leo Pharma, said: “The approval of Enstillar may offer the appropriate plaque psoriasis patients a new treatment option in an elegant vehicle that provides rapid relief from symptoms.

“We are excited about the approval of Enstillar as it represents another step in Leo Pharma's unwavering commitment to helping patients living with this chronic, often debilitating disease.”

Enstilar (calcipotriene/betamethasone dipropionate) is a once-daily, alcohol free foam formulation in a pressurised can that allows application across large areas of the body.

Adverse reactions were reported in less than 1% of patients and included skin irritation, folliculitis and exacerbation of psoriasis.

The new approval means that Enstilar will now compete with other oral drugs for psoriasis such as Celgene's Otezla (apremilast) as well as Pfizer's Enbrel (etanercept), which is coming under competition from numerous biosimilars.

Additionally, newer entrants like Lilly's ixekizumab and Novartis' Consentyx (sekucinumab) are expected to further drive growth of the global psoriasis market from $6bn in 2012 to nearly $9bn by 2023. 

Article by
Nikhil Patel

21st October 2015

From: Regulatory

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