GSK's gets FDA thumbs up for new asthma drug Nucala

UK pharma major GlaxoSmithKline (LSE: GSK) late yesterday received approval from the US Food and Drug Administration for its Biologics License Application (BLA) for Nucala(mepolizumab) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

This is the first marketing authorization granted for mepolizumab anywhere in the world, the company noted. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for Nucala earlier this year (The Pharma Letter September 24).

Sales potential

The launch of six novel biologics for asthma are forecast to double the sales of biologics over the forecast period from just over $1 billion in 2014 to $2 billion in 2024, according to a recent report from Decision Resources (TPL September 23). This also suggests that, with its first-to-market status, Nucala will be the sales leader among the six anticytokines. Analysts on average expect the drug to generate annual sales of $756 million by 2020, according to Thomson Reuters data.