LONDON, July 21 (Reuters) - The European Medicines Agency on Friday recommended approval of Regeneron Pharmaceuticals and Sanofi’s new drug Dupixent for atopic dermatitis, a product many analysts see as the most important growth driver for the two companies.
Recommendations from the agency’s expert committee on new drugs are normally endorsed by the European Commission within a couple of months.
Atopic dermatitis is a chronic type of skin inflammation also known as eczema, which in severe cases causes constant, often unbearable, itching.
The U.S. Food and Drug Administration approved Dupixent in March.
Dupixent is also being developed for severe asthma, where it will compete with a wave of other new biotech medicines, such as GlaxoSmithKline’s Nucala, as well as for nasal polyps.
In a pivotal late stage study, after 16 weeks of treatment with 300 milligrams of Dupixent either weekly or every two weeks along with topical corticosteroids, 39 percent had achieved clear or nearly clear skin compared with 12 percent of patients who received the topical treatment alone. (Reporting by Ben Hirschler)