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GSK's COPD drug Incruse cleared in Europe

Medicine is GSK’s first long-acting muscarinic antagonist
GSK - logo on building

GlaxoSmithKline has rounded out its chronic obstructive pulmonary disease (COPD) franchise in Europe with the approval of Incruse, its first long-acting muscarinic antagonist (LAMA).

The European Commission gave a green light to Incruse (umeclidinium) as a once-daily maintenance treatment to relieve symptoms in adults with COPD. It is not approved for use in asthma.

Darrell Baker, who heads up GSK's global respiratory franchise, said that Incruse is an important drug for the company as it is "our first LAMA".

The drug is delivered using GSK's new Ellipta dry powder inhaler and is a constituent in GSK's combination COPD therapy Anoro, which also contains long-acting beta agonist (LABA) vilanterol. Anoro was recommended for approval in the EU in February and is just being launched in the US having become the first LAMA/LABA combination to be approved by the FDA late last year.

The combination therapy is tipped as a blockbuster with sales approaching $2bn a year at peak, although that is still some distance short of the $8bn a year GSK makes from current COPD blockbuster Seretide/Advair (salmeterol and fluticasone), which is facing the threat of generic competition as well as removal from the formularies of some pharmacy benefits managers in the US.

As a monotherapy, Incruse fleshes out the franchise by providing an alternative single-agent option, as well as add-on option for COPD patients who need additional bronchodilation but want to continue on their current medicine. It also gives GSK a direct competitor to Boehringer Ingelheim/Pfizer's LAMA Spiriva, which along with Advair accounted for two thirds of all COPD sales in 2012.

The first launches of Incruse are due to take place in Europe by the end of 2014, said GSK, adding that the approval is based on seven phase III trials which included over 2,500 COPD patients who were treated with either umeclidinium or placebo.

Incruse has also recently been approved in Canada, although the marketing application for umeclidinium as a monotherapy is still under review in the US.

Article by
Phil Taylor

29th April 2014

From: Sales



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