An FDA advisory panel voted in favor of a GlaxoSmithKline COPD treatment, whose proposed brand name is Anoro, on Tuesday with an 11-2 endorsement. The drug candidate is a unique combination in the respiratory space because it combines both a long-acting muscarinic antagonist and a long-acting beta agonist.
Marketing clearance for Anoro could also provide a bit of insulation for the drug maker, which is facing possible generic competition to its medication Advair, a possibility that is becoming more likely based on recent FDA draft guidance that could make it easier for generics to get into the Advair market space.
Glaxo has been working to shore up its COPD position, with efforts including Anoro as well as the recently approved Breo Ellipta.
The FDA is expected to rule on the drug in December. The advisory panel’s vote does not mean the drug is approved, but is taken into consideration by the agency.
An approval would also reverse a recent downbeat string of news for GSK, including last week’s announcement that the company’s Phase III melanoma treatment missed its target and failed to significantly extend disease-free survival. The company said Friday that it was going to continue with the trial to see if it achieves its secondary endpoint. GSK expects this data to roll in in 2015.