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Pharmaceuticals / Submissions and Approvals

FDA Approves GSK's Asthma Drug Arnuity for Ellipta Inhaler

Aug. 28, 2014

The FDA has cleared GlaxoSmithKline’s asthma drug Arnuity, adding a fourth product to GSK’s growing portfolio of respiratory drugs administered through its dry-powder inhaler Ellipta.

Arnuity (fluticasone furoate) won approval as a once-daily inhaled corticosteroid for patients 12 years and older. It is not indicated for relief of acute bronchospasm. The drug’s safety and efficacy were evaluated in more than 3,600 patients with asthma, GSK said.

“It is the first asthma treatment from our new portfolio to have gained approval in the U.S. and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients,” said Darrell Baker, senior vice president and head of GSK Global Respiratory Franchise.

The drug joins GKS’s Breo, Anoro and Incruse, all of which treat Chronic Obstructive Pulmonary Disease (COPD), for use with the Ellipta inhaler.

The company now is investigating additional uses of the inhaler. For example, GKS is testing Breo to treat asthma and a combination product of Breo and Anoro to treat COPD, a GSK spokesman said.

Asthma affects about 26 million people in the U.S., and inhaled corticosteroids like Arnuity are the cornerstone in managing persistent asthma, interest groups said. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.