GSK gets FDA blessing for new indication for Nucala

The Food and Drug Administration has given the green light to GlaxoSmithKline for a new indication for Nucala (mepolizumab). The drug now is approved to treat adults and children aged 12 years and older with hypereosinophilic syndrome for six months or longer without another identifiable non-blood-related cause of the disease.

"Today's approval marks the first time in over a decade that there is a new FDA-approved treatment option for patients with hypereosinophilic syndrome," said Ann Farrell, director of the division of Nonmalignant Hematology in the FDA's Center for Drug Evaluation and Research. "FDA is committed to helping develop safe and effective treatment options for this group of rare and debilitating blood diseases and other rare conditions."

HES is a heterogeneous group of rare disorders associated with persistent eosinophilia (higher than normal levels of a type of disease-fighting white blood cell) with evidence of organ damage. Symptoms include skin rashes, itching, asthma, difficulty breathing, abdominal pain, vomiting, diarrhea, arthritis, muscle inflammation, congestive heart failure, deep venous thrombosis (blood clots in the veins) and anemia.

Nucala also is approved for patients aged 6 years and older with severe asthma with an eosinophilic phenotype and for adult patients with eosinophilic granulomatosis with polyangiitis, a rare autoimmune condition that causes blood vessel inflammation.