New Asthma Rx Approved

Breo Ellipta from GlaxoSmithKline and Theravance approved to treat asthma in adults by FDA

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Adult asthma patients will soon have a new treatment available to them.

The US Food and Drug Administration (FDA) Thursday approved Breo Ellipta (fluticasone furoate, an inhaled corticosteroid) to treat asthma. The once-daily asthma treatment from GlaxoSmithKline (GSK) and Theravance Inc. is only approved for use in adults.

"Breo Ellipta is our second asthma treatment to be approved in the US in the past year, and now provides physicians with a range of treatment options delivered via the Ellipta inhaler to meet the needs of appropriate adult patients with differing asthma severities,” said Darrell Baker, head of the GSK Global Respiratory Franchise, in a press release.

Asthma is a chronic lung disease in which the airways are inflamed, which can cause them to swell, narrow and produce too much mucus. Symptoms include coughing, wheezing and shortness of breath.

The FDA approved Breo Ellipta after the drug was studied in more than 12,000 patients in 23 trials and appeared safe and effective. According to GSK, Breo Ellipta may raise patients' risk of certain heart effects, such as increased pulse, raised blood pressure and irregular heartbeat.

Breo Ellipta should not be used to treat asthma attacks (acute bronchospasms), GSK noted.

Review Date: 
May 1, 2015
Last Updated:
May 5, 2015