LONDON (Alliance News) - GlaxoSmithKline PLC said Friday that the Pulmonary Allergy Drugs Advisory Committee of the US Food and Drug Administration voted unanimously that efficacy and safety data for mepolizumab supported its approval for adults aged 18 or older with severe asthma.
The committee voted against approval of mepolizumab for use in adolescents aged between 12 and 17 with severe asthma. It voted that the efficacy and safety of mepolizumab had not been adequately demonstrated for this age group mostly due to the limited number of patients in the age group in the overall database. It recommended further data is needed in this group.
"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," said President of Glaxo's Pharmaceuticals Research and Development Patrick Vallance in a statement.
"GSK will continue to work closely with the FDA to complete the review of the BLA for mepolizumab," Vallance said.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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