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Theravance, GSK Win FDA Clearance for COPD Therapy Breo

By Randy Osborne
Staff Writer

Less than a month after the FDA's Pulmonary-Allergy Drugs Advisory Committee bestowed its favor on inhaled Breo (fluticasone furoate [FF]/vilanterol [VI]), the combination corticosteroid and long-acting beta2 agonist (LABA) for chronic obstructive pulmonary disease (COPD) from GlaxoSmithKline plc and Theravance Inc., the FDA granted approval for the compound.

Evaluating Breo as a maintenance therapy, the panel's vote was 9-4 in favor, and as a treatment to reduce COPD exacerbations, the tally came out the same, though one member said he had intended to vote against recommending approval, and accidentally voted yes. But before that snafu came votes 12-1 in favor of Breo's efficacy as a maintenance therapy, 8-5 in favor of efficacy against exacerbations and 10-3 positive for safety in the proposed indications.

In all, it was enough for the agency to green-light Breo, even though briefing documents ahead of the advisory committee meeting had created a mood of some uncertainty, as they cited inconsistent data with Breo. Analysts, though, said the skepticism was not as deep as might have been feared, and most predicted ultimate approval.

And so it was, although Breo carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and efficacy of Breo Ellipta in patients with asthma have not been established, and it is not approved for the treatment of asthma.

Officially branded Breo Ellipta, the treatment will be marketed with a patient medication guide that includes instructions for use and details about the potential risks of taking the drug. Among the warnings: The drug should not be used as a rescue therapy to treat sudden breathing problems (acute bronchospasm) and is not recommended for people younger than 18 years.


See Monday's BioWorld Today for More on This Story.