Regulators raise an eyebrow at GSK lung disease drug efficacy

Jul 23, 2018

Expert reviewers at the FDA have cast doubt over the effectiveness of a drug GlaxoSmithKline said could be used to treat patients with COPD.  

The medication, called Nucala, has already been approved for patients with severe asthma. Now, GSK is gunning for an indication for patients whose COPD symptoms have suddenly become more severe. 

On Monday, the agency’s expert panel published documents taking issue how Nucala failed in one late-stage trial but then succeeded in another. They also questioned how GSK had defined the patient population being targeted for this use of Nucala.  

The expert advisory committee is expected to give the agency their final recommendation on the drug’s use for COPD this week.