GSK receives first FDA approval for injectable asthma drug

GlaxoSmithKline’s (GSK) Nucala is the first anti-interleukin-5 (anti-IL-5) treatment for severe asthma approved by the US Food and Drug Administration (FDA)

Nucala is to be taken by patients who have a history of severe asthma attacks despite receiving their current asthma medicines.

Badrul Chowdhury, director of the division of pulmonary, allergy, and rheumatology products in the FDA's centre for drug evaluation and research, said: "This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma."

Nucala is administered once every four weeks by subcutaneous injection by a health care professional every four weeks and reduces severe asthma attacks by reducing the levels of blood eosinophils - a type of white blood cell that contributes to the development of asthma.

Three double-blind placebo controlled trials showed patients with severe asthma receiving Nucala had fewer attacks requiring hospitalisation and emergency department visits.

Eric Dube, senior vice president and head, GSK Global Respiratory Franchise, said: "GSK can now offer a first-in-class biologic treatment for severe asthma patients whose condition is driven by eosinophilic inflammation.

“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.”