FDA Rejects GSK’s Breo Ellipta Asthma Therapy Use in Adolescents; Adult Use Approved

FDA Rejects GSK’s Breo Ellipta Asthma Therapy Use in Adolescents; Adult Use Approved

GSK Incruse Ellipta COPDThe U.S. Food and Drug Administration (FDA) ruled against the use of GlaxoSmithKline‘s new drug combination Breo Ellipta in asthma patients between the ages of 12 and 17. However, the Pulmonary-Allergy Drugs Advisory Committee and the FDA’s Risk Management Advisory Committee approved the therapy’s supplemental New Drug Application (sNDA) in patients older than 17.

The decision was made and announced in a press release by the two groups in a joint meeting after the examination of data provided by GSK on the effectiveness of Breo Ellipta (fluticasone furoate/vilanterol [FF/VI]) as an inhaled treatment for asthma to be administrated once a day.

“We recognise the Advisory Committee’s thoroughness in reviewing the data related to Breo Ellipta for asthma,” said the SVP & Head of GSK Global Respiratory Franchise, Darrell Baker. “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.”

The committee voted in favor of Breo Ellipta to treat asthma in adults older than 17 years due to the results from efficacy and safety studies conducted regarding FF/VI 100/25 mcg and 200/25 mcg once daily, as well as in favor of the clinically meaningful benefit demonstrated by the efficacy data from GSK studies that provided substantial evidence on the efficacy and safety of the treatment among these patients.

However, the members of the committee voted against the proposal of using Breo Ellipta for the treatment of adolescents between the ages of 12 and 17 years old. The decision was made based on the lack of data supporting the efficacy and safety of the treatment for that age demographic. In addition, the committee advised GSK to conduct a major LABA safety trial with FF/VI with both adults and adolescents, resembling the one currently being undertaken as FDA Post-Marketing Requirement.

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Breo Ellipta is an inhaled drug combination that includes both corticosteroid and vilanterol and works by softening the interior of the airways. The medication is already being commercialized in the US for the treatment of chronic obstructive pulmonary disease (COPD) and GSK submitted the sNDA last June regarding two once-daily dose regimens, 100/25 mcg and 200/25 mcg.

The FDA also recently filled a preliminary report regarding the investigational combined therapy that revealed no additional safety issues, and there were no deaths among patients with asthma who were treated with Breo Ellipta in the studies conducted and reviewed by the administration. The FDA is now expected to present the final decision by April 30, which is the Prescription Drug User Fee Act goal date, taking into consideration the FDA Advisory Committee’s non-binding recommendations.

The president and CEO of Theravance, Inc., Michael W. Aguiar, added that “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. We look forward to the final outcome expected in April.”

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