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Home Industry News GlaxoSmithKline receives CHMP backing for new COPD therapy

GlaxoSmithKline receives CHMP backing for new COPD therapy

21st February 2014

GlaxoSmithKline and partner Theravance have received a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for approval of a new therapy for chronic obstructive pulmonary disease (COPD).

The companies' new umeclidinium/vilanterol combination therapy – which will be sold under the proposed brand name Anoro – has been endorsed as a once-daily, maintenance bronchodilator treatment to relieve symptoms in adult COPD patients.

Positive data from a phase III pivotal programme spanning seven clinical studies informed the European Medicines Agency committee's decision to recommend the drug for approval.

A final decision by the European Commission is anticipated during the second quarter of 2014. The therapy has already been approved in the US and Canada under the name Anoro Ellipta.

Patrick Vallance, GlaxoSmithKline's president of pharmaceutical research and development, said: "Today's positive opinion is a step towards us making this important new medicine available. We are looking forward to the final decision of the European Commission in the near future."

This comes after the company received a positive CHMP opinion for approval of the new diabetes therapy Eperzan last month.ADNFCR-8000103-ID-801696092-ADNFCR

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