Regeneron Pharmaceuticals Inc. and Sanofi SA received U.S. FDA approval for Dupixent injection for the treatment of atopic dermatitis, the most common form of eczema.
The drug is approved to treat adults with moderate to severe atopic dermatitis when the disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Dupixent was evaluated by the FDA with priority review after the regulatory body's breakthrough therapy designation for the drug in 2014.
Regeneron and Sanofi Genzyme, Sanofi's specialty care global business unit, will market the drug in the U.S. The drug is expected to be available to patients and providers in the U.S. in the week of March 27.
U.K. regulators have granted the drug an investigational treatment status for atopic dermatitis, which means that patients can buy the drug before it is granted marketing authorization in the U.K.