GSK suffers setback as its asthma drug fails to win expanded FDA approval for COPD

By PharmaCompass

2018-09-13

Impressions: 122 Article

British drugmaker GlaxoSmithKline faced a setback a few days back when its bid to expand the use of its biologic Nucala in the US to include patients with coronary pulmonary obstructive disorder (COPD) got rejected by the FDA.

The company is seeking approval for Nucala (mepolizumab) as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with COPD, guided by blood eosinophil counts.

The FDA issued a complete response letter (CRL) to GSK that more clinical data are required to support an approval. GSK filed for the drug’s approval for COPD on the basis of two trials - Metrex and Metreo.

GSK will work closely with the FDA to determine the appropriate next steps for the supplementary biologics license application (sBLA), the company said in a statement.

Nucala is a monoclonal antibody, already approved for asthma, that works by inhibiting interleukin-5 (IL5) to decrease the maturation and survival of eosinophils (a type of disease-fighting white blood cells), overproduction of which can cause inflammation in the lungs.

Soon after receiving the CRL from the FDA for Nucala as an add-on COPD treatment, GSK released data that showed the same medication was a superior treatment in severe eosinophilic asthma in patients with similar blood eosinophil counts.

GSK released data from an indirect treatment comparison between Nucala and AstraZeneca's Fasenra (benralizumab) and Teva’s Cinqair (reslizumab). It showed Nucala “significantly reduced clinically significant exacerbations and improved asthma control” compared to the other two branded products.

Meanwhile, last week the European Commission approved Nucala for the treatment of children with severe asthma. The marketing authorization for Nucala has been granted as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients aged six to 17 years.

As a result of this license extension, Nucala is now approved for use in severe refractory eosinophilic asthma in both adult and pediatric patients in the 31 European countries covered by the European Medicines Agency (EMA).

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