FDA panel backs approval of GSK's mepolizumab for severe asthma

June 17, 2015

The FDA’s Pulmonary-Allergy Drugs Advisory Committee recently recommended approval of GlaxoSmithKline Plc's drug mepolizumab (Nucala) for severe asthma patients 18 and older.

FDA’s Pulmonary-Allergy Drugs Advisory Committee recently recommended approval of GlaxoSmithKline Plc's drug mepolizumab (Nucala) for severe asthma in patients aged 18 years and older.

However, the panel voted 10 to 4 against approving the drug in children aged 12 to 17 years, according to a Reutersarticle.

If approved, mepolizumab would be the first new biologic treatment for severe asthma in more than a decade. “The Committee…voted that the efficacy data provided substantial evidence of a clinically meaningful benefit in this population, and safety in adults with severe asthma had been adequately demonstrated,” according to a GlaxoSmithKline statement.

Related:FDA approves Breo Ellipta for treatment of asthma in adults

“Our clinical development programme has demonstrated the potential of mepolizumab as a targeted treatment for difficult to treat adults with severe asthma, many of whom have been struggling to live with their condition for many years,” said Patrick Vallance, president of GSK’s Pharmaceuticals R&D. “These are patients who currently have very few treatment options and our belief in this medicine as a new treatment option has today been reinforced by the Advisory Committee’s decision.”

The BLA for mepolizumab was submitted to FDA in November 2014 for approval as an add-on maintenance treatment for patients with severe asthma with eosinophilic inflammation, identified by a blood eosinophil count of at least 150 cells per μL at the start of treatment or 300 cells per  μL in the past 12 months.

Mepolizumab is not currently approved for use anywhere in the world. Regulatory filings in a number of other countries, including the EU and Japan, are under way, according to GSK.