Atopic Dermatitis Treatment Placed on Accelerated FDA Approval Track

Sanofi and Regeneron Pharmaceutics, Inc, have convinced the FDA that their atopic dermatitis (AD) treatment works well enough to undergo accelerated development and regulatory review.

The FDA has granted breakthrough therapy designation to dupilumab for the treatment of adults with moderate-to-severe AD in whom topical prescription therapy is inappropriate or inadequate.

With this designation, development and review of dupilumab will be expedited. To qualify for this designation, substantial improvement over available therapies or significant improvements compared with placebo must be evident.

In a press release, the 2 manufacturers explained that their investigational therapy for the serious form of eczema blocks 2 cytokines required for type 2 helper T-cell immune response, which is a pathway in allergic inflammation.

“Moderate-to-severe atopic dermatitis is a debilitating, life-altering disease with very limited treatment options. Many patients suffer for years with widespread inflamed skin, debilitating itch, sleep disturbances, and other challenges,” said Julie Block, chief executive officer at the National Eczema Association, in a press release. “We are thrilled to see that the FDA recognizes the need to expedite and prioritize potential new options for these patients.”

In addition to itching and sleeping problems, AD is also associated with other inflammatory disorders, such as asthma.