Regulators in Europe have given the green light to GlaxoSmithKline’s new chronic obstructive pulmonary disease drug Incruse.
Specifically, the European Commission has granted marketing authorisation for Incruse (umeclidinium) as a once-daily treatment to relieve symptoms in adults with COPD. The drug is a once-daily long-acting muscarinic antagonist (LAMA) delivered by GSK’s Ellipta inhaler.
Darrell Baker, head of GSK’s global respiratory franchise, noted that COPD affects millions of people in Europe “and for many years we have been committed to researching and improving understanding of it”. He added that the firm is delighted to get approval for Incruse, “our first LAMA, which will provide healthcare professionals with a further treatment option”.
The first launches will take place in Europe by the end of 2014 and the approval is based on seven Phase III trials which included over 2,500 COPD patients treated with umeclidinium or placebo.
A New Drug Application for umeclidinium monotherapy was submitted to the US Food and Drug Administration a year ago and is still under review. Regulators approved Incruse earlier this month.
News of the thumbs-up came as GSK announced that Anoro, which combines umeclidinium and the long-acting beta2 (LABA) agonist vilanterol is now available to retail pharmacies in the USA. The combo, which is partnered with Theravance, was approved by the FDA in December 2013.
