FDA approves antibody-based eczema drug

Providers now have new options for treating residents who have difficult cases of eczema.

The U.S. Food and Drug Administration (FDA) has approved Dupixent, a new injection antibody treatment, for adults with moderate to severe eczema that is not controlled well by topical medications. Dupixent includes an antibody (dupilumab) that binds to the protein responsible for inflammation, reducing the inflammatory response that triggers atopic dermatitis.

Efficacy and safety clinical trials show that most adults experience clearer skin and less itching after 16 weeks of receiving the twice-a-month treatment.

The hurdle for providers may be its price, at least initially. The drug's manufacturers, Regeneron Pharmaceuticals and Sanofi, say the wholesale price of the drug is expected to be around $37,000 per year.

Regeneron and Sanofi are being proactive about negotiating the price of the drug with insurers, seeking coverage for the drug under benefits plans, since it has no real competition at the moment. “Things have really deteriorated in our industry,” Dr. Leonard S. Schleifer,  CEO of Regeneron, told the New York Times. “There’s so much concern over drug pricing that there’s an enormous amount of finger-pointing that is going on that’s counterproductive. It isn’t necessarily incentivizing the right behavior.”

The drug received approval through the FDA’s Priority Review and Breakthrough Therapy processes, designed to fast-track drugs that have great promise.

Topics: Clinical