GSK inhaler contender faces FDA panel Tuesday

Share this article:

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.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...