UK drug regulator warns of eye-related side effects after Sanofi/Regeneron Dupixent therapy
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The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday warned patients of risks of ocular adverse reactions after treatment with Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals' (NASDAQ:REGN) drug Dupixent (dupilumab).
The MHRA said healthcare professionals prescribing dupilumab should be alert to the risks of ocular reactions and new onset or worsening ocular symptoms require prompt review.
The U.K. drug regulator noted that dupilumab is commonly linked with cases of conjunctivitis and allergic conjunctivitis, eye pruritus, blepharitis, and dry eye and with infrequent cases of keratitis and ulcerative keratitis, especially in patients with atopic dermatitis.
The agency added that most side effects of the eye are mild, but some can become serious if they are not managed properly.
The MHRA noted that sudden changes in vision or significant eye pain which does not settle requires urgent review.
Up to Sept. 7, the MHRA received 479 U.K. reports which included suspected ocular side effects with dupilumab, with 111 reports considered serious. Nine reports of ulcerative keratitis, representing five cases. Two of these cases involved corneal perforation. There were 18 reports involving children aged between 6 years to 17 years, according to the MHRA.
The agency said that U.K. clinical experience is that dupilumab does not usually need to be discontinued in the event of ocular reactions. However, patients and healthcare professionals should recognize serious reactions, and when ophthalmological referral is necessary.