Regulatory Focus™ > News Articles > GSK's new COPD Therapy Wins FDA Approval

GSK's new COPD Therapy Wins FDA Approval

Posted 10 May 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's chronic obstructive pulmonary disorder (COPD) drug Breo Ellipta (fluticasone furoate and vilanterol inhalation powder), just weeks after an FDA advisory council gave the drug its stamp of approval.

The drug is a combination of the inhaled corticosteroid fluticasone furoate and a long-acting bronchodilator, vilanterol. In a statement, FDA said the drug, which had undergone clinical testing in nearly 8,000 patients, represented a new option to provide long-term control over COPD.

"We know that one of the main issues for patients who have experienced a COPD exacerbation is concern about possible future episode," said Darrel Baker, SVP of GSK's Global Respiratory Franchise, in a statement. "Breo Ellipta will help patients breathe better day-to-day and reduce the risk of future exacerbations, with a once-daily inhalation."

FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) voiced its approval for the drug on 17 April 2013, but did so on a 9-4 basis regarding its efficacy, and 10-3 regarding its safety. At least one member indicated that he wanted to change his vote regarding the drug's efficacy, which would have made the efficacy vote 8-5.

And while the drug's safety profile may not have been substantial enough to delay or prevent its approval, FDA indicated that it still had some reservations that would result in the drug receiving numerous restrictions. The drug will carry a boxed warning regarding a potential increase in asthma-related death, as well as a mandatory patient medication guide meant to educate consumers about the potential risks of taking it. FDA noted that Breo Ellipta is not meant to be used as a rescue therapy, and is not meant to be used by those under the age of 18.

Other serious side effects include pneumonia, bone fractures, inflammation of the nasal passage, upper respiratory tract infection, thrush and headache.

Read FDA's approval statement here.

Tags: GSK, approval, NDA

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