FDA approves GlaxoSmithKline’s Nucala drug for severe asthma

Nucala is approved as an add-on maintenance treatment for patients aged 12 and older. It is administered once every four weeks by injection.

The drug is a monoclonal antibody that inhibits interleukin-5 (IL-5), which helps regulate eosinophils, a type of white blood cell that contributes to asthma.

The over-production of eosinophils can lead to inflammation in the lungs, increasing the frequency of asthma attacks.

In three studies, patients who received Nucala had fewer asthma attacks that needed hospitalization or emergency-room visits and reported longer breaks between attacks.

GSK said patients should consider a varicella vaccination, if medically appropriate, before commencing therapy with Nucala.

Patients are also advised to take other medications, including high-dose inhaled corticosteroids and at least one additional asthma drug.

FDA Center for Drug Evaluation and Research director of the division of pulmonary, allergy, and rheumatology products Badrul Chowdhury said: "This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma."

GSK Global Respiratory Franchise senior vice president Eric Dube said: "Our research has allowed us to better understand the specific role eosinophils play in severe asthma.

"We are proud of our contribution to this emerging area of science that has led to the approval of the first anti-IL5 treatment. We aim to offer this medicine to patients as soon as possible."

Image: GlaxoSmithKline, Center City, Philadelphia. Photo: courtesy of Beyond My Ken.