GSK hit with US FDA knockback for COPD application

The decision was expected after the US Food and Drug Administration (FDA)’s advisory committee voted 16 to 3 against approving the drug in July of this year.

During the committee’s evaluation, the risk-benefit profile was not deemed strong enough to warrant extending Nucala (mepolizumab)’s indication to patients suffering from chronic obstructive pulmonary disease (COPD).

The monoclonal antibody (mAb) treatment has already been approved to treat severe asthma and a condition called eosinophilic granulomatosis with polyangiitis – an autoimmune condition of the blood vessels.

However, the company was unable to complement these approvals with what would have been the first biologic approval for COPD, as an add-on treatment to inhaled corticosteroid-based maintenance treatment.

GSK stated that it received a complete response letter (CRL) from the FDA asking for the company to provide further data on the use of Nucala for COPD and that it will work with the agency to determine the next steps of the application.

At the time of its approval, Nucala was expected to play a significant role​ in boosting GSK’s position in the respiratory sector. In this year’s second quarter financials, the product brought in sales of £141m ($183m) but still has some way to go to make up for falling sales in Advair, for which sales fell by 28% to $590m.