Glaxo’s Nucala nabs accelerated review in U.S. for rare white blood cell disorder

The FDA grants Priority Review status to GlaxoSmithKline’s (NYSE:GSK) marketing application seeking approval to use Nucala (mepolizumab) to treat hypereosinophilic syndrome, a group of rare conditions associated with abnormally high levels of a type of white blood cell called eosinophils that leads to organ damage. The IL-5 antagonist also has Fast Track and Orphan Drug status for the indication.

Priority Review shortens the review clock to six months from the standard 10 months.

https://seekingalpha.com/news/3577800-glaxos-nucala-nabs-accelerated-review-in-u-s-for-rare-white-blood-cell-disorder