UPDATE 1-GSK receives European nod for COPD drugs Anoro, Incruse

Thu Feb 20, 2014 5:02pm EST

LONDON Feb 20 (Reuters) - Anoro, a combination drug for chronic obstructive pulmonary disease (COPD) developed by GlaxoSmithKline and Theravance, has received the green light from European regulators, the companies said on Thursday.

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

The drug, in a different strength formulation, was approved by regulators in the United States and Canada in December 2013.

It is expected to generate annual sales of about $2.65 billion by 2018, Thomson Reuters data showed when it received U.S. approval.

The British company said later on Thursday that umeclidinium had also been recommended for approval as a monotherapy for the same condition.

Marketed under the brand name Incruse, like Anoro it is designed as a once-daily, maintenance treatment for COPD, a disease which typically affects smokers.

Some of the data submitted for both drugs came from the same trials, GSK said.

Recommendations for marketing approval from the European Medicines Agency are usually followed by the granting of full marketing authorisation by the European Commission within months.

Respiratory drugs are a major franchise for GSK. Advair, its market leading lung drug, makes up a fifth of its sales but it is already facing competition from generic versions in Europe.

Chief Executive Andrew Witty said earlier this month that the launch of new drugs such as Anoro would help it stay ahead of rivals in respiratory medicine.

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