GlaxoSmithKline receives licence approval recommendation for asthma treatment drug

12th Jun 2015 07:08

Pharmaceutical and healthcare giant GlaxoSmithKline announced on Friday that the advisory committee of the US Food and Drug Administration (FDA) has recommended its Mepolizumab drug be granted a biologics licence application (BLA) for use in the treatment of adults with severe asthma.However, it voted against approving the drug for use in adolescents aged 12-17 years, mainly because of the limited number of patients in that age group involved in the study, and said further data was needed in this sub-population where there is a high unmet need.Mepolizumab is not currently approved for use anywhere in the world.President of the company's pharmaceuticals research and development division, 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. GSK will continue to work closely with the FDA to complete the review of the BLA for mepolizumab."