Incyte gets blessing from FDA for Opzelura skin cream use in younger children

"With this approval, we are now able to offer younger children with atopic dermatitis and their families a much-needed, steroid-free topical treatment option with the potential to significantly improve the burdensome symptoms they experience every day," said Bill Meury, CEO of  Incyte. "At Incyte, we are committed to delivering innovative solutions that address every stage of a patient's journey; this approval is another step toward addressing the real-world challenges faced by patients suffering from chronic skin conditions, including people living with atopic dermatitis."

 The approval came after successful late-stage trials that demonstrated the effectiveness of the cream.

 The overall safety profile of Opzelura in the TRuE-AD3 trial was consistent with previous data. The most common adverse reaction was upper respiratory tract infection.

 AD, the most common type of eczema, is a chronic immune-mediated skin disease, which in the U.S. affects an estimated two to three million patients ages 2-11 and more than 21 million people 12 years of age and older. Signs and symptoms include irritated skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral, and fungal infections.

In September 2021, Opzelura was approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years and older.

Sales of Opzelura hit the $500 million mark last year. It's one of the company's drugs  that addresses the "patent cliff"  Incyte  is facing in the future for its blockbuster blood disorder drug Jakafi. 

Incyte is based near Wilmington and is moving its headquarters to downtown Wilmington.

Despite some disappointing trial results, Incyte shares are up 23% this year.

Further clilnical trial information is available at  https://www.clinicaltrials.gov/study/NCT04921969.