Sanofi and Regeneron announce FDA approval of Dupixent

“People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives,” said Julie Block, President and Chief Executive Officer, National Eczema Association. 

“To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease.  That’s why today’s approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease,” he said.

Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. Dupixent comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose.

Dupixent can be used with or without topical corticosteroids. It should not be used in patients who are allergic to dupilumab or any of the ingredients in Dupixent.

AD, the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe AD is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating.

Of the adults with uncontrolled moderate-to-severe AD in the United States, it is estimated that 300,000 are most in need of new treatment options.

“Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases.  In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease,” said George D. Yancopoulos, M.D., Ph.D., Founding Scientist, President, and Chief Scientific Officer, Regeneron. 

“Today’s approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global LIBERTY AD clinical program,” said he.

Dupixent was evaluated by the FDA with Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions.

This followed the FDA’s 2014 Breakthrough Therapy designation for Dupixent for inadequately controlled moderate-to-severe AD. Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs developed for serious or life-threatening conditions/ Dupixent represents the first time this designation was granted for a dermatological disease, other than in dermatologic cancers. 

“We strive to transform scientific innovation into therapeutic solutions that make a meaningful difference to people’s lives,” said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi.

“The approval of Dupixent offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally,” said he.

Sanofi Genzyme, the specialty care global business unit of Sanofi, and Regeneron will market Dupixent in the United States. Dupixent is expected to be available to patients and providers in the U.S. later this week.

Sanofi and Regeneron recognize that Dupixent can only help those uncontrolled moderate-to-severe AD patients that were prescribed the medicine if they can both access the medicine and use it properly.

Therefore, the companies have launched Dupixent MyWayTM, a comprehensive and specialized program that provides support and services to patients throughout every step of the treatment process.

Dupixent MyWayTM will help eligible patients who are uninsured, lack coverage, or need assistance with their out-of-pocket costs. Additionally, Dupixent MyWayTM offers personalized support from registered nurses and other specialists who are available 24/7 to speak with patients and help them navigate the complex insurance process.

The Wholesale Acquisition Cost (WAC) of Dupixent in the United States is $37,000 annually. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts, rebates or patient assistance programs.