The FDA has approved GSK’s supplemental NDA for the Breo Ellipta fluticasone furoate/vilanterol DPI, allowing GSK to market the inhaler for the treatment of asthma in patients aged 18 years and older. Breo Ellipta was approved by the FDA for the treatment of COPD in May 2013.
In March 2015, the FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee voted in favor of Breo Ellipta for the treatment of asthma in adults but recommended against approval for children aged 12-17. According to GSK and Theravance, the FDA has issued a complete response letter related to pediatric use, saying that it lacked sufficient safety and efficacy data in that population.
GSK Senior VP and Head, GSK Global Respiratory Franchise, Darrell Baker commented, “Asthma is a variable condition and guidelines recommend a stepwise approach to treatment with the aim of achieving asthma control. Breo Ellipta is our second asthma treatment to be approved in the US in the past year, and now provides physicians with a range of treatment options delivered via the Ellipta inhaler to meet the needs of appropriate adult patients with differing asthma severities.”
Theravance President and CEO Michael W. Aguiar said, “We believe the approval of Breo Ellipta as a once-daily ICS/LABA treatment for adults with asthma is a significant catalyst for Theravance, as asthma affects nearly 19 million adults in the US. We are pleased by today’s approval of Breo Ellipta and look forward to making this important medicine available to the appropriate adult patients among those living with the disease.”
Read the GSK and Theravance press release.
