Reuters logo
BRIEF-UK regulator gives positive opinion on Sanofi/Regeneron's dupilumab product
2017年3月14日 / 早上8点42分 / 6 个月前

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

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).

Source text for Eikon:

我们的标准汤森路透“信任原则”
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below