GlaxoSmithKline's Nucala garners FDA approval for patients with severe asthma

GlaxoSmithKline said that it received FDA approval for Nucala (mepolizumab) as an add-on maintenance treatment for patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. The company noted the biologic therapy is the "first anti-IL5 treatment for adults and adolescents with severe asthma with an eosinophilic phenotype."

According to GlaxoSmithKline, Nucala is administered as a 100mg fixed-dose subcutaneous injection every four weeks. The drugmaker added that patients will receive Nucala in addition to their normal medications for severe asthma, which include high-dose inhaled corticosteroids plus at least one additional asthma control medicine, and may include oral corticosteroids. GlaxoSmithKline said the drug is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

The FDA indicated that the approval of Nucala was based on three trials in patients with severe asthma on currently available therapies. Results showed that compared with placebo, those who received Nucala had fewer exacerbations requiring hospitalisation or emergency department visits, and a longer time to the first exacerbation. In addition, the agency said that patients with severe asthma receiving Nucala experienced greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control compared with patients receiving placebo.

Eric Dube, head of GlaxoSmithKline's global respiratory franchise, commented "following today's approval, [GlaxoSmithKline] can now offer, as part of our overall respiratory portfolio, a first-in-class biologic treatment for severe asthma patients whose condition is driven by eosinophilic inflammation." The company noted that the approval marks "the first marketing authorisation granted for [Nucala] anywhere in the world."

In September, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of Nucala as an add-on treatment for severe refractory eosinophilic asthma in adults. Analysts predict that the drug will generate annual sales of $756 million by 2020.

For related analysis, read Physician Views: GlaxoSmithKline's Nucala – what opportunity in severe eosinophilic asthma? For more information on the US asthma market, see Market Access Impact: Asthma/COPD (US).

To read more Top Story articles, click here.