FDA Advisors Recommend Asthma Drug Approval in Adults
An FDA advisory committee has unanimously recommended approval for GlaxoSmithKline's mepolizumab severe asthma treatment in adults, but not adolescents.
An FDA advisory committee has unanimously recommended approval for GlaxoSmithKline’s mepolizumab severe asthma treatment in adults, but not adolescents.
The FDA’s Pulmonary Allergy Drugs Advisory Committee voted 14-0 that efficacy and safety data for mepolizumab—an anti-interluekin-5 monoclonal antibody delivered subcutaneously every 4 weeks at a fixed dose of 100 mg—supports its approval in adult patients with severe asthma with eosinophilic inflammation.
The same committee voted 4-10 against approving the add-on asthma maintenance treatment in adolescents aged 12 to 17 years, however, indicating the efficacy and safety of mepolizumab has not yet been adequately demonstrated in this population.
“Our clinical development program 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 pharmaceuticals R&D for GSK. “These are patients who currently have very few treatment options, and our belief in this medicine as a new treatment option has…been reinforced by the advisory committee’s decision.”
GSK submitted the Biologics License Application for mepolizumab in November 2014. The FDA is expected to act on that application on November 4, 2015.
Mepolizumab is also being evaluated as an adjunctive therapy for adults with severe chronic obstructive pulmonary disease.