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Pfizer’s next blockbuster given FDA approval

Published on 15/12/16 at 12:28pm

Pfizer announced that it had received approval for its eczema treatment, Eucrisa, for patients of two years of age and older. The treatment of mild to moderate atopic dermatitis (AD) is usually by a topical steroid but Pfizer’s is a new non-steroid treatment. Pfizer expects Eucrisa to achieve annual peak sales of $2 billion.

The drug was acquired through Pfizer’s purchase of Anacor Pharmaceuticals, in a deal worth $5.2 billion. It will become the first and only non-steroidal topical monotherapy for treatment of eczema. Therein lies part of the hope in selling the drug, with an option for patients who react badly to steroids or who do not wish to risk the potential side-effects of thinning skin. 90% of patients who suffer from eczema suffer from mild to moderate and there are approximately 35 million sufferers in the US alone.

“The approval of Eucrisa is great news for the children and adults suffering from mild to moderate eczema, a community that has not had a new prescription treatment for more than 10 years,” said Albert Bourla, Group President, Pfizer Innovative Health. “This is also an important milestone for Pfizer as we continue to build on our heritage in Inflammation and Immunology by offering innovative treatment options to patients who need them.”

The approval of Eucrisa was based on two clinical trials involving 1,522 people with mild to moderate AD, with the primary efficacy endpoint was success in ISGA at day 29, defined as the proportion of patients achieving an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline. The studies found that people treated with Eucrisa displayed a 32.8% improvement against 25.4% in the non-medicated ointment in the first trial and 31.4% versus 18.0% improvement in the second trial.

Ben Hargreaves

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