Johnson & Johnson announced that the U.S. Food and Drug Administration has granted Priority Review to its drug IMAAVY (nipocalimab) for the treatment of warm autoimmune hemolytic anemia (wAIHA), a rare and life-threatening blood disorder.

Priority Review shortens the FDA evaluation timeline to around six months and is reserved for therapies that may offer significant improvements over existing options. Notably, IMAAVY is the first treatment to receive this designation for wAIHA, where no approved therapies currently exist.

Source: PRNewswire