A federal advisory panel recommended approval of GlaxoSmithKline Plc's new drug to treat chronic obstructive pulmonary disease (COPD), but suggested the company be required to conduct further safety studies once the drug is approved.
The panel of expert advisers to the U.S. Food and Drug Administration voted 11-2 on Tuesday to approve the inhaled drug, Anoro Ellipta, which is designed to improve lung function in people with the disease, which is typically associated with smoking.
Anoro is a combination of vilanterol, a long-acting beta-agonist (LABA) which opens the airways, and umeclidinium, a long-acting muscarinic receptor antagonist (LAMA) which improves lung function. GSK is developing the product with partner Theravance Inc.
The FDA is not required to follow the advice of its advisory panels but typically does so.
Anoro is expected to generate sales of more than $2 billion a year by 2018, according to the average estimate of six analysts polled by Thomson Reuters. A decision is expected by December 18.
Much of the panel's discussion centered on the drug's safety profile, which showed an imbalance in the number of non-fatal heart attacks experienced by patients taking Anoro in certain clinical trials compared with those taking a placebo.
A similar imbalance was not seen in a longer study of the drug at a higher dose, however, leaving many panel members scratching their heads and worried that additional heart problems could emerge once the drug is used outside the closely-monitored confines of a clinical trial.
Dr. James Stoller, chair of the Education Institute at the Cleveland Clinic, said the data left him with a "non-specific sense of unease" and he voted against the drug.
Even some of those who voted in favor of Anoro did so with hesitation. Dr. David Jacoby, professor of medicine at Oregon Health and Science University, said he was "very borderline" on his decision and continues to have "serious concerns" about whether the drug will prove safe if used in a broad COPD patient population.
"I strongly support warnings in the labeling and a post-marketing study," he said.
The panel voted unanimously that the drug is effective.
COPD is the third-leading cause of death in the United States, according to federal data. The condition can include emphysema, chronic bronchitis, or both.
Investment analysts had been expecting a positive recommendation.
"This should serve as a reminder to investors that GSK is entering an exciting period of new drug launch activity after many largely barren years," said Mark Clark, an analyst at Deutsche Bank, in a research note.
Elaine Jones, GSK's medicine development leader for Anoro, said in an interview after the vote that the company will meet with the FDA to discuss the next steps for the drug.
"I thought the meeting was very scientific," Jones said. "I think it was a great debate."
In May, the FDA approved another drug for COPD made by the two companies called Breo Ellipta. Breo is an inhaled combination of vilanterol and the corticosteroid fluticasone furoate, which reduces inflammation. That drug is expected to generate $1.9 billion by 2018.
LABA and LAMA drugs are already sold individually and a number of other drug companies, including Novartis AG, AstraZeneca Plc and Boehringer Ingelheim, which makes the LAMA drug Spiriva, are betting that LABA/LAMA inhalers will become the first choice of treatment for COPD.
The current market-leading drugs to treat COPD include Spiriva and GSK's Advair, with $8 billion in annual sales.
The positive Anoro news comes as investors worry that new draft guidance from the FDA for making generic versions of Advair, which is also approved to treat asthma, will make it easier than expected for generics to reach the market.
Theravance Chief Executive Rick Winningham said the panel's decision makes for a "transformative year" for the company, which plans to split into two publicly traded entities, separating the respiratory drugs it is developing with Glaxo from its other operations.
After the split, the company holding the respiratory drugs will be called Royalty Management Co. The second company, to be called Theravance Biopharma, will focus on developing drugs for rare diseases.
The move has fueled speculation that Glaxo, which owns 27 percent of Theravance, may eventually buy Theravance's most lucrative products.
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