The FDA has approved GSK and Theravance’s Breo Ellipta fluticasone furoate/vilanterol inhalation powder for the treatment of COPD). The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted to recommend approval of Breo Ellipta in April 2013. Theravance will make a $30 million milestone payment to GSK following the approval.
The FDA notes that, “The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and efficacy of Breo Ellipta in patients with asthma have not been established, and it is not approved for the treatment of asthma.”
Director of the Office of Drug Evaluation of the FDA’s Center for Drug Evaluation and Research (CDER) Curtis Rosebraugh commented, “The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”
GSK Global Respiratory Franchise Senior VP and Head Darrell Baker reacted: “This approval means that we can now realize our plan to bring Breo Ellipta to appropriate COPD patients in the US. We know that one of the main issues for patients who have experienced a COPD exacerbation is concern about possible future episodes. Breo Ellipta will help patients breathe better day-to-day and reduce the risk of future exacerbations, with a once-daily inhalation.”
According to GSK and Theravance, the inhalation powder, which is delivered using the Ellipta DPI, should be available in the third quarter of this year.
Read the FDA press release.
Read the GSK and Theravance press release.
