Johnson & Johnson Wins First FDA Label Expansion for Imaavy
Johnson & Johnson secured an FDA label expansion for Imaavy, approving the FcRn blocker to treat warm autoimmune hemolytic anemia in patients ages 12 and older who use or have used corticosteroids. In a trial of 115 participants, three times as many patients on the 30 mg/kg dose achieved durable hemoglobin gains versus placebo at 24 weeks. J&J views Imaavy as a potential blockbuster with peak sales potential of $5 billion or more.