Despite “fragile” trial data, the FDA should approve Abbott Laboratories’ proposed new indication for its blockbuster Humira to treat ulcerative colitis (UC) because new therapies for the chronic condition are needed and clinicians are comfortable with the drug’s safety profile, agency advisers say. More studies are needed to clarify lingering safety and dosing concerns raised by the data, but they should take place after approval, the FDA’s Gastrointestinal Drugs Advisory Committee said Tuesday.
Drug Industry Daily