March 14, 2017 / 8:41 AM / in 4 months

BRIEF-UK regulator gives positive opinion on Sanofi/Regeneron's dupilumab product

1 Min Read

March 14 (Reuters) - Sanofi:

* Sanofi says UK's Medicines & Healthcare Products Regulatory Agency (MHRA) has granted dupilumab, a product which treats for atopic dermatitis (AD), a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).

* The decision means that eligible adults with severe atopic dermatitis can access dupilumab before the drug is granted marketing authorisation in the UK, Sanofi adds in statement

* Dupilumab is currently under joint development with Regeneron and Sanofi and its safety and efficacy have not been fully evaluated by any regulatory body. The formal EU regulatory application for dupilumab is currently under review by the European Medicines Agency (EMA).

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