Advertisement
asthma

New Once-Daily Asthma Treatment Approved

The US Food and Drug Administration approved once-daily Breo Ellipta (fluticasonefuriate/vilanterol) for the treatment of patients with asthma who are 18-years-old or older.
_______________________________________________________________________________________________________________________________________________________________

RELATED CONTENT
Bariatric Surgery Helps Relieve Asthma Symptoms
Tiotropium Improves Lung Function in Severe Asthma
_______________________________________________________________________________________________________________________________________________________________

“We believe the approval of Breo Ellipta as a once-daily ICS/LABA treatment for adults with asthma is a significant catalyst for Theravance, as asthma affects nearly 19 million adults in the US,” said Michael W. Aguiar, President and Chief Executive Officer of Theravance, Inc.

“We are pleased by today’s approval of Breo Ellipta and look forward to making this important medicine available to the appropriate adult patients among those living with the disease,” he said.

Breo Ellipta, a dry powder inhaler, was approved in 2 strengths—100/25mcg and 200/25mcg. It is a fixed-dose combination of fluticasone furoate (FF), an inhaled corticosteroid (ICS), and vilanterol (VI) the long-acting beta-2 agonist (LABA).

To determine the efficacy and safety of Breo Ellipta, researchers conducted a clinical trial including over 12,000 participants (12 years and older) in 23 studies.

Researchers discovered that participants between 12 and 17 years who were administered Breo Ellipta did not see adequate risk-benefit to allow approval in those patients.

Patients can be weaned off of therapy once asthma control is achieved and maintained.

-Michelle Canales Butcher

Reference:

GSK. FDA approves BREO ELLIPTA for the treatment of adults with asthma in the US. April 30, 2015. http://us.gsk.com/en-us/media/press-releases/2015/fda-approves-breo-ellipta-for-the-treatment-of-adults-with-asthma-in-the-us/. Accessed April 30, 2015.