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Home Industry News GlaxoSmithKline receives US recommendation for COPD drug approval

GlaxoSmithKline receives US recommendation for COPD drug approval

19th April 2013

GlaxoSmithKline and Theravance have announced that their new treatment for chronic obstructive pulmonary disease (COPD) has been recommended for regulatory approval in the US.

The product – which is to be called Breo Ellipta in the US and is also known as Relvar in Europe – received a favourable decision from the US Food and Drug Administration's Pulmonary-Allergy Drugs Advisory Committee, based on positive results from clinical trials.

It has been shown to be beneficial for COPD patients struggling with airflow obstruction and can also help to reduce COPD exacerbations in patients with a history of such incidents.

The European Medicines Agency is also currently considering an application submitted in June 2012 to approve Relvar as a treatment for COPD and asthma.

Patrick Vallance, GlaxoSmithKline's president of pharmaceutical research and development, said: "This positive recommendation is a crucial first step towards making Breo Ellipta available for appropriate COPD patients across the US."

GlaxoSmithKline and Theravance are also seeking US and European approval for another COPD therapy called Anoro.ADNFCR-8000103-ID-801574010-ADNFCR

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