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Pfizer’s Eczema Drug Gains FDA Approval

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FDA

The drug is a non-steroidal topical phosphodieterase-4 (PDE-4) inhibitor, which is approved for use in patients over the age of two.

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December 16, 2016 | by Sarah Hand, M.Sc.

The US Food and Drug Administration (FDA) has approved Pfizer’s Eucrisa (crisaborole), a novel treatment for mild to moderate atopic dermatitis – also known as eczema. The drug is a non-steroidal topical phosphodieterase-4 (PDE-4) inhibitor, which is approved for use in patients over the age of two.

“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.”

According to Pfizer, almost 18 million people in the US have been diagnosed with eczema, 90 percent of whom have the mild to moderate form of the chronic condition. An overactive PDE-4 enzyme has been associated with an increase in eczema-associated symptoms.



While Eucrisa is the first and only drug of its kind to inhibit the PDE-4 enzyme, its mechanism of action has not been fully elucidated. Two randomized, controlled clinical trials involving 1,522 patients between the ages of two and 79 showed that Eucrisa was statistically significant in terms of efficacy, compared to the vehicle alone.

“I’m delighted to have a new option for my patients with mild to moderate atopic dermatitis,” said Dr. Amy Paller, Walter J. Hamlin Professor and Chair of Dermatology, Professor of Pediatrics, Northwestern University Feinberg School of Medicine, and a clinical trial investigator. “The results seen in these pivotal Phase 3 studies show the efficacy and safety of Eucrisa as a steroid-free treatment option for people as young as two living with mild to moderate atopic dermatitis.”

Pfizer acquired Eucrisa in May, after it bought-out California-based Anacor Pharmaceuticals. According to data and analytics company, GlobalData, the eczema market is expected to reach $7.3 billion by the year 2024.


Keywords: Eczema, FDA, Prescription Drug


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