GlaxoSmithKline's Nucala hopes take a hit with FDA panel thumbs-down in COPD

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GSK's Nucala won its original severe asthma approval in 2015. (Eric Sagonowsky)

As would-be rivals struggled with winning FDA approvals in the last few years, GlaxoSmithKline's key respiratory franchise has reaped the benefit. But now, the company is suffering a setback of its own.

Nucala, a key player in the company's respiratory ambitions, failed to win an FDA advisory panel's backing to treat chronic obstructive pulmonary disease patients with high eosinophilic counts, a much bigger market than its current target in severe eosinophilic asthma. The panel voted 16-3 Wednesday against a COPD approval; though 17 panelists backed its safety in a separate vote, 16 said there wasn't enough evidence to show Nucala is effective for those COPD patients.

Afterward, GlaxoSmithKline SVP of R&D in respiratory Dave Allen said the company will continue to work with the regulator to "address outstanding questions." The FDA doesn't have to follow its panel votes, but it typically does. Nucala's decision date at the agency is Sept. 7. 

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"We remain confident our data supports (Nucala) as a targeted treatment for patients continuing to experience COPD exacerbations guided by blood eosinophil count," Allen said.

If approved, Nucala would be the first biologic to treat COPD, GSK says. The FDA originally approved the drug in 2015 as an add-on treatment for patients 12 and older with severe asthma. GSK applied to expand the drug's use to COPD last November.

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The committee vote marks a setback as GSK and AstraZeneca square off with their respective respiratory biologics. AstraZeneca's Fasenra won approval last year and planned a “very, very competitive" launch, respiratory VP Tosh Butt said in an interview. Since then, AstraZeneca's drug failed a pair of COPD trials, cooling ambitions for an expansion into that field. Last week, England's cost watchdogs ruled that Fasenra is appropriate for asthma patients who can't use GSK's Nucala, prompting disappointment from AZ.

For Glaxo, the panel vote came right after the company reported second-quarter results. During the conference call discussion, CEO Emma Walmsley reported that the company doesn't plan to spin out its consumer health unit, contrary to recent reports. Instead, GSK is kicking off a cost-cutting drive and revamping its R&D structure to focus on the immune system. With the cost-cutting push, GSK aims to save £400 million per year by 2021, but the effort will cost £1.7 billion over the next three years, executives said.

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While the panel vote is a negative development for GSK, the company has on several occasions benefited from agency decisions for would-be rivals in the respiratory field. Its leading drug Advair has dodged generic competition numerous times—most recently with a Mylan rejection. Mylan's rejection follows another regulatory stumble by that company, plus others for partners Hikma and Vectura, and Novartis' Sandoz.

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