Glaxo's combo respiratory drug deemed safe by FDA staff
- There have been concerns about vilanterol-related asthma deaths, forcing Glaxo to extensively test Breo Ellipta, which contains a corticosteroid and vilanterol, and submit the results to the FDA.
- Breo Ellipta is already approved for the treatment of chronic obstructive pulmonary disorder (COPD), and is currently being reviewed by the FDA to determine whether it will be approved for the treatment of asthma.
- Vilanterol is a long-acting beta-adrenoreceptor agonist (LABA) that has been linked to asthma-related deaths.
In preparation for an upcoming meeting in the next two days to discuss approval of Breo Ellipta for an asthma indication, the FDA reviewed a total of 23 studies conducted by GSK. The agency concluded that asthma-related hospitalizations were not uniformly observed.
Currently, GSK has three drugs on the market, which contain LABA as part of a respiratory treatment combination formulation. In each case, labeling explicitly warns of the risk of asthma-related death. The common thinking now is that Breo Ellipta is not any different in terms of risk than the other three drugs that are already on the market and approved. And on the upside, Breo Ellipta delays worsening of asthma symptoms, largely because of the LABA component.
An asthma indication approval by the FDA is looking likely for Breo Ellipta.