GSK and Theravance receive FDA approval for COPD treatment in US

11th Sep 2013 07:04

GlaxoSmithKline (GSK) has, alongside partner Theravance, announced that the US Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) has recommended approval of their latest treatment for chronic obstructive pulmonary disease (COPD) in the US. The committee voted 11-to-two in favour of a recommendation for the UMEC/VI treatment. GSK described the development as "good news". The proposed name for the product is Anoro Ellipta, and it will consist of a combination of two investigational bronchodilator molecules: one a long-acting muscarinic antagonist; and the other a long-acting beta2 agonist, administered via an inhaler. The committee also voted that the safety of the investigational medicine has been adequately demonstrated at the 62.5/25mcg dose for the proposed indication, while the efficacy data provided substantial evidence of a clinically meaningful benefit for UMEC/VI 62.5/25mcg once daily for the long-term, maintenance treatment of airflow obstruction in COPD. Patrick Vallance, GSK's President of Pharmaceuticals Research & Development, said: "Today's recommendation is good news and a reflection of our commitment to giving an alternative treatment option for patients living with COPD - a disease that affects millions of Americans. "If approved, Anoro Ellipta will be the first, once-daily dual bronchodilator available in the US, marking another significant milestone for GSK's portfolio of medicines to treat respiratory disease. We will continue to work with the FDA as they complete their review."The UMEC/VI clinical development programme involved over 6,000 COPD patients.NR