FDA Panel Recommends Asthma Treatment Approval for Adults Only

The FDA’s advisory committee supports the approval of fluticasone furoate/vilanterol (Breo Ellipta) for the treatment of asthma in adults, but not in children aged 12 to 17 years.

In a joint meeting, the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 16-4 that efficacy and safety data on the once-daily inhaled treatment provides enough evidence to support approval for use in adults aged 18 years and older with asthma.

However, the panel voted 2-18 against approving the treatment for use in asthma patients aged 12 to 17 years, citing that the efficacy data did not adequately demonstrate benefit and safety has not been demonstrated sufficiently.

The supplemental new drug application submitted by GlaxoSmithKline (GSK) and Theravance seeks FDA approval for Breo Ellipta in asthma patients aged 12 years and older.

"We recognize the advisory committee's thoroughness in reviewing the data related to Breo Ellipta for asthma,” said Darrell Baker, senior vice president and head of GSK’s Global Respiratory Franchise, in a press release. “We will continue to work closely with the FDA while it considers the Committee's recommendations and our aim is to answer any outstanding questions to enable them to make a fully informed decision."

Based on the available data and opinions provided by the advisory committee, the FDA is expected to make a final decision on the treatment’s approval on April 30, 2015.

"We remain committed to the ongoing review process and will be fully cooperating with the FDA to ensure it has all it needs to consider the sNDA for Breo Ellipta in asthma,” said Michael Aguiar, president and chief executive officer of Theravance, in the press release. “We look forward to the final outcome expected in April."