MHRA Recommends Updated Labeling of Dupixent

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has recommended updated product labeling for Sanofi and Regeneron’s blockbuster eczema drug Dupixent (dupilumab) to include dry eye as a potential adverse reaction.

The agency said that the drug is commonly associated with cases of conjunctivitis and allergic conjunctivitis, eye pruritus and blepharitis in addition to dry eye, adding that it has also received reports of ulcerative keratitis with serious corneal damage.

The agency said it has received 479 reports of suspected ocular side effects from Dupixent, 111 of which were considered serious.