LONDON Feb 20 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
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
The British company said later on Thursday that umeclidinium
had also been recommended for approval as a monotherapy for the
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
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.