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Home Industry News GlaxoSmithKline receives CHMP backing for Relvar Ellipta

GlaxoSmithKline receives CHMP backing for Relvar Ellipta

20th September 2013

GlaxoSmithKline and Theravance have announced that Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended their new drug Relvar Ellipta for approval.

The European Medicines Agency committee have issued a positive opinion endorsing marketing authorisation for the fluticasone furoate/vilanterol therapy for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Data from clinical studies involving more than 17,000 patients have demonstrated the safety and efficacy of the drug in both of these respiratory indications, with the US Food and Drug Administration having already approved the new treatment for sale.

Patrick Vallance, GlaxoSmithKline's president of pharmaceutical research and development, said the company "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".

The firm also announced this week that Relvar Ellipta has been approved for the treatment of asthma in Japan.ADNFCR-8000103-ID-801639934-ADNFCR

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