GlaxoSmithKline and Theravance have announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the Relvar Ellipta fluticasone furoate/vilanterol (FF/VI) DPI for the treatment of asthma for patients who require a combination inhaler for adequate control and for the treatment of COPD patients with an FEV1 less than 70% of the predicted normal after treatment with a bronchodilator and with a history of exacerbations.
GSK President of Pharmaceuticals R&D Patrick Vallance commented, “Asthma and COPD are two of the most common respiratory conditions and affect millions of patients across Europe. GSK has been researching and developing these molecules as a potential new combination treatment for over ten years and today’s opinion brings it one step closer to patients. What is particularly exciting is that we have achieved the first of what we hope in the future could be many positive regulatory outcomes supporting the potential use of FF/VI in appropriate patients with asthma. We eagerly await the final decision of the European Commission in the near future.”
The two companies also announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Relvar Ellipta for the treatment of asthma where an ICS/LABA combination is necessary for control of symptoms. GSK and Theravance withdrew their application for the use of Relvar Ellipta for the treatment of COPD in Japan in July 2013. The approval triggers a $10 million milestone payment from Theravance to GSK.
Theravance CEO Rick E Winningham said, “The approval of Relvar Ellipta will provide Japanese physicians with a new, important once-daily, inhaled treatment option for their asthma patients. This first approval of Relvar Ellipta in asthma represents yet another significant milestone in the respiratory partnership between Theravance and GSK.”
In the US, where the FF/VI inhaler is known as Breo Ellipta, the FDA approved the product for the treatment of COPD in May 2013. Breo Ellipta was also approved for the treatment of COPD in Canada in July 2013.
Read the GSK/Theravance press release on the CHMP recommendation.
Read the GSK/Theravance press release on Japanese approval of Relvar Ellipta.
