PADAC has 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 recommended to deliver as a 100mg fixed dose through a subcutaneous injection every four weeks to treat adults with severe asthma.
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 showed.
Additionally, PADAC voted against approval of mepolizumab for use in adolescents 12 to 17 years of age with severe asthma.
The committee has not recommended the approval for the drug through a vote of four to 10.
They also noted 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.
GSK pharmaceuticals R&D president Patrick Vallance said: "Our clinical development programe 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."
The company has submitted BLA for mepolizumab to the FDA in last November seeking approval as an add-on maintenance treatment for patients with severe asthma with eosinophilic inflammation.
The FDA Prescription Drug User Fee Act (PDUFA) goal date for mepolizumab is 04 November 2015.
Currently, mepolizumab is not approved for use anywhere in the world, while regulatory filings in a number of other countries, including the EU and Japan, are underway.