UK Drug Regulator Warns Of Severe Eye Reactions Associated With Sanofi/Regeneron's Dupixent

UK Drug Regulator Warns Of Severe Eye Reactions Associated With Sanofi/Regeneron's Dupixent
  • The UK's Medicines and Healthcare Regulatory Agency (MHRA) warned of some new and severe eye-related side effects following the use of Sanofi SA SNY and Regeneron Pharmaceuticals Inc's REGN atopic dermatitis and asthma treatment Dupixent (dupilumab).
  • Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye, and infrequent cases of keratitis and ulcerative keratitis.
  • The MHRA added that health professionals should look for any of these eye-related side effects as "it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis."
  • Related: Dupixent, Flu Vaccine Demand Boost Sanofi's Q3 Earnings, Lifts Annual Outlook.
  • Despite the new warning, expert ophthalmology and dermatology advice to the MHRA indicated that most ocular reactions seen with dupilumab are mild and manageable.
  • As of September 7, the MHRA has received 479 UK reports, including suspected ocular side effects with dupilumab. 
  • Of those, 111 reports were considered serious, MHRA said, noting that nine reports of ulcerative keratitis were received, representing five cases, and two of these cases involved corneal perforation. Eighteen reports involved children ranging from 6 to 17 years of age.
  • Price Action: REGN shares are up 0.73% at $741.48 premarket on the last check Wednesday. SNY shares are down 2.99% at $44.50.

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