FDA Approves Asthma Drug

On Thursday, the U.S. Food and Drug Administration (FDA) approved an asthma medication.

GlaxoSmithKline (GSK) announced that it had received approval for fluticasone furoate/vilanterol (Breo Ellipta) as a once-daily dry powder inhaler for adult patients with asthma.

Two doses of the medication are available, 100/25 mcg and 200/25mcg.

The drug was approved to treat individuals with chronic obstructive pulmonary disease in May 2013.

While being reviewed for this approval, the drug showed no new safety issues. However, long-acting beta-andrenoceptor agonists have been linked with asthma-related deaths.

Patients with asthma taking the medication experienced the following adverse reactions: influenza, headache, upper respiratory tract infection, oral candidiasis, sinusitis, dysphoria, cough, oropharyngeal pain, and nasopharyngitis.

The medication is not approved for acute bronchospasm. The FDA noted in its letter to GSK that the agency did not find sufficient proof that the medication that the benefits significantly outweighed the risks for patients ages 12-17.

--Stephanie Vaccaro

Reference:

1. GlaxoSmithKline. FDA approves Breo Ellipta for the treatment of adults with asthma in the US [press release]. www.gsk.com. 2015 Apr 30.