pulmonary

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for GlaxoSmithKline (GSK) and Theravance’s umeclidinium/vilanterol (UMEC/VI), under the brand name ‘Anoro’, for treatment of chronic obstructive pulmonary disease (COPD).

The drug is a combination of umeclidinium, a long-acting muscarinic antagonist (LAMA) that helps lung function, and vilanterol, a beta agonist that opens the airways, in a single inhaler, the Ellipta.

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GSK president of Pharmaceuticals R&D Patrick Vallance 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."

The European Commission’s final decision on UMEC/VI is expected during the second quarter of 2014 and its proposed strength is 55mcg / 22mcg.

Theravance chief executive officer Rick Winningham said: "This is an important milestone and reflects the ongoing efforts of the collaboration between Theravance and GSK to research and develop new respiratory medicines that meet patient needs."

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The Phase III programme for UMEC/VI included seven clinical trials in about 6,000 patients with COPD.

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In December 2013, the US Food and Drug Administration and Health Canada had approved Anoro Ellipta 62.5mcg / 25mcg for use in appropriate patients with COPD.

In Europe, the UMEC/VI strength of 55mcg / 22mcg is specified as the delivered dose, which is equivalent to the 62.5mcg / 25mcg pre-dispensed dose approved in the US and Canada.

"This is an important milestone and reflects the ongoing efforts of the collaboration between Theravance and GSK to research and develop new respiratory medicines that meet patient needs."

In April, a regulatory submission for UMEC/VI under the trade name Anoro Ellipta was submitted in Japan and is currently under review.

Anoro Ellipta is not indicated for the relief of acute bronchospasm or for treating asthma.

UMEC/VI is an investigational medicine and is not currently approved anywhere in the world outside of the US and Canada.

Separately, CHMP has also issued a positive opinion recommending marketing authorisation for umeclidinium under the proposed brand name Incruse as a once-daily, maintenance treatment to relieve symptoms in adult patients with COPD.

Umeclidinium is an investigational long-acting muscarinic antagonist (LAMA) and the proposed strength is 55mcg inhalation powder contained in the Ellipta inhaler.

The EMA evaluation of of umeclidinium included a review of seven Phase III clinical trials, which covered more than 2,500 COPD patients treated with umeclidinium or placebo.

Image: Incruise, Anoro and Ellipta are trademarks of the GlaxoSmithKline group of companies. Photo: courtesy of freedigitalphotos.net.