GSK and Theravance have announced that the European Commission has approved Relvar Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of asthma for patients whose disease is not adequately controlled by ICS plus an as-needed SABA and for COPD where patients do not have adequate control with regular bronchodilator use. Relvar has been approved in different strengths for the treatment of asthma, 92/22 mcg and 184/22 mcg, and only 92/22 mcg for the treatment of COPD.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of Relvar Ellipta in September 2013. The approval triggers a $15 million milestone payment from Theravance to GSK; Theravance will pay GSK an additional $15 million once Relvar is launched in Europe.
GSK Senior VP and Head of the Global Respiratory Franchise Darrell Baker commented, “For many years GSK has been focused on developing a portfolio of new treatments for patients across the world with asthma and COPD. We are delighted that Relvar Ellipta is now licensed, which means that healthcare professionals across Europe will have the option to prescribe an ICS/LABA that offers 24-hour efficacy from a once-daily dose, delivered in our new Ellipta inhaler.”
Theravance CEO Rick E Winningham said, “This is yet another important achievement and is testament to our successful partnership with GSK in respiratory disease. We are delighted that another significant regulatory body has granted marketing authorization for Relvar Ellipta for the treatment of asthma and COPD and look forward to seeing the benefits of this effective once-daily treatment option in these patient populations.”
In the US, the FDA approved the product, known as Breo Ellipta, in May 2013, and the product was launched in the US in October 2013.
Read the GSK/Theravance press release.
