GalaxoSmithKline received FDA approval for an expanded use of its severe asthma drug Nucala and granted the drug Orphan status.
Nucala can now be used in adults for the treatment of a rare autoimmune disease, eosinophilic granulomatosis with polyangiitis, which causes vasculitis, an inflammation in the wall of blood vessels. EGPA, formerly known as Churg Strauss Syndrome, is a condition characterized by asthma, high levels of a type of white blood cell and inflammation in blood vessels.
The FDA first approved Nucala in 2015 to treat patients with severe asthma with an eosinophilic phenotype.