PARIS (Reuters) – The U.S. Food & Drug Administration (FDA) regulator has given more positive feedback on the Dupixent eczema treatment being developed by drugmakers Sanofi and Regeneron, the companies said on Tuesday.
Dupixent was launched in the United States in April 2017 for the treatment of moderate-to-severe eczema in adults, and the product is seen as a key sales driver for both companies.
They said the FDA had accepted for a priority, or expedited, review the license application for the use of Dupixent in adolescents aged 12 to 17 with moderate-to-severe atopic dermatitis, where the disease was inadequately controlled with topical therapies, or when such treatment was medically inadvisable.
Last month, Dupixent also received approval from the FDA as an additional maintenance therapy in patients with two types of asthma.
Dupixent had revenues of 225 million euros ($256.8 million) in the third quarter, Sanofi reported in October, as the company also lifted its overall 2018 profit target.
Sanofi and Regeneron are developing Dupixent to treat conditions including paediatric asthma, chronic sinus infection with nasal polyps, and adolescent eczema.
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Reporting by Sudip Kar-Gupta; editing by Richard Pullin and Kirsten Donovan