GSK

The US Food and Drug Administration’s (FDA) pulmonary allergy drugs advisory committee (PADAC) has recommended approval for British drugmaker GlaxoSmithKline’s (GSK) mepolizumab treatment for adults with severe asthma.

The committee recommended the drug through a unanimous voting of 14 to zero, supporting the biologics licence application (BLA) for mepolizumab as an add-on maintenance treatment for severe asthma with eosinophilic inflammation.

Mepolizumab is an anti IL-5 monoclonal antibody that is recommended to deliver as a 100mg fixed dose through a subcutaneous injection every four weeks.

GSK pharmaceuticals R&D president Patrick Vallance said: "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.

"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."

"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."

The committee said that the efficacy data provided substantial evidence of a clinically meaningful benefit in patient population and safety in adults with severe asthma had been adequately demonstrated.

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In addition, the committee voted against approval of mepolizumab for use in adolescents aged 12 to 17 years with severe asthma. This was a rejected with a vote of ten to four.

The committee said that the mepolizumab had not been adequately demonstrated, primarily due to the limited number of patients in the 12-17 age group in the overall database.

In November 2014, the company submitted BLA for mepolizumab for approval as an add-on maintenance treatment for patients with severe asthma with eosinophilic inflammation.


Image: Obstruction of the lumen of a bronchiole by mucoid exudate, goblet cell metaplasia, and epithelial basement membrane thickening in a person with asthma. Photo: courtesy of Yale Rosen.