FDA panel to review death risk for asthma treatment

fda logo FDA panel to review death risk for asthma treatmentBreo Ellipta, a drug used to treat chronic obstructive pulmonary disease (COPD), did not cause any asthma related deaths in a series of clinical studies conducted by the drug’s maker, GlaxoSmithKline (GSK). The studies will be reviewed by a Food and Drug Administration (FDA) advisory panel, which will decide whether to recommend the medication as a safe treatment for asthma.

The safety label of Breo Ellipta currently includes a warning that compounds in the drug called long-acting beta2-adrenergic agonists can increase the risk of asthma-related deaths.

The clinical trial data submitted by GSK included three deaths however none were related to the Breo Ellipta. Other serious complications associated with the medication were also rare, according to the data.

Breo Ellipta was approved as a COPD treatment in May 2013. At that time, the FDA said that the safety and efficacy of the medication in asthma patients had not been clearly determined.

GSK is seeking to gain FDA approval of Breo Ellipta for the treatment of asthma, and the advisory committee is scheduled to review the new data this week. The FDA has asked the panel whether larger-scale studies are needed to better establish the drug’s safety among asthma patients.

The FDA is not required to follow the advice of its expert panels, though it usually does.

Source: Law 360