FDA panel supports approval of Glaxo lung drug Anoro

FDA panel supports approval of Glaxo lung drug Anoro

By Toni Clarke

WASHINGTON | Tue Sep 10, 2013 3:43pm EDT

WASHINGTON (Reuters) - A federal advisory panel recommended approval of GlaxoSmithKline's new drug to treat chronic obstructive pulmonary disease (COPD), and suggested the company be required to conduct further safety studies afterwards.

The panel of expert advisers to the U.S. Food and Drug Administration voted 11-2 to approve the inhalant drug, Anoro, to help improve lung function in people with the disorder often associated with smoking.

Anoro is a combination of vilanterol, which is designed to open the airways, and umeclidinium, which works to improve 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.

The drug is expected to generate sales of more than $2 billion a year by 2018, six analysts polled by Thomson Reuters estimated on average. A decision is expected by December 18.

Much of the panel's discussion centered on the drug's safety profile, particularly an imbalance in the number of non-fatal heart attacks seen in patients taking Anoro in shorter clinical trials compared with those taking a placebo.

A similar imbalance was not seen in a longer safety study, however, leaving many panel members scratching their heads and worried that the drug may increase the risk of cardiovascular problems in sicker patients.

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 the drug 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 when used outside the confines of a clinical trial.

"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 is often associated with smoking and can include emphysema, chronic bronchitis, or both.

Investment analysts had been expecting a positive recommendation.

In May, the FDA approved another drug for COPD made by the two companies called Breo. 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.

(Reporting by Toni Clarke in Washington; Editing by Carol Bishopric and Richard Chang)