GSK inhaler contender faces FDA panel Tuesday

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An FDA advisory committee is set to review a novel entry in the COPD inhaler market that could shake up the category.

The candidate is GlaxoSmithKline/Theravance's experimental drug Anoro, a combination of a long-acting beta agonist and a long-acting muscarinic antagonist. Currently approved COPD inhalers fall into an either/or category.

The go-to names in the COPD inhaler category tend to be GSK's Advair and Boehringer Ingelheim/Pfizer's Spiriva, which Decision Resources noted last month accounted for about two-thirds of COPD market sales in 2012. Analysts from Decision Resources said they expect Advair's dominance to fall, and for the brand to retain less than 15% of market share once new agents enter the space.

Advisory panel paperwork for the two-in-one drug appears to favor the experimental therapy. The Bernstein analyst Tim Anderson noted in a September 6 research note that FDA researchers called out the safety profile, and cited “the overall low number of events observed in the clinical development program, which is reassuring.”

Anderson wrote that the “thirst for a LABA/LAMA combination,” and long-term safety studies' lack of a cardiac signal, make it likely that the panel will support the drug's approval.

The FDA is expected to rule on the drug in December. The advisory panel's vote does not determine if the drug is approved, but is taken into consideration. Regulatory approval would add oomph to a recent downbeat string of news, 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.
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