FDA nods to Pfizer’s skin disease drug

U.S. Food and Drug Administration (FDA) has approved Pfizer’s  Eucrisa (crisaborole) ointment 2%, a novel non-steroidal topical phosphodieterase-4 (PDE-4) inhibitor for the treatment of mild to moderate atopic dermatitis (AD) in patients two years of age and older.

Atopic dermatitis, often called eczema, is a chronic condition impacting nearly 18 million children and adults in the United States. Approximately 90 percent of people living with this disease have the mild to moderate form of the condition.

“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.”

Pfizer noted in its press release issued on Wednesday that Eucrisa is the first and only non-steroidal topical monotherapy that inhibits the PDE-4 enzyme in the skin. Overactive PDE-4 has been shown to contribute to the signs and symptoms of AD.4 The specific mechanism of action of crisaborole in AD is not well defined.1

“I’m delighted to have a new option for my patients with mild to moderate atopic dermatitis,” said Amy Paller, M.D., Walter J. Hamlin Professor and Chair of Dermatology, Professor of Pediatrics, Northwestern University Feinberg School of Medicine, 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.”