GSK share price steady as FDA panel backs use of asthma drug only in adults

on Jun 12, 2015
Updated: Oct 21, 2019

An advisory committee of the US Food and Drug Administration (FDA) has backed the use of GlaxoSmithKline Plc’s (LON:GSK) drug mepolizumab for use in adult patients with severe asthma. The panel, however, voted against approving the compound as a treatment for children aged between 12 and 17.

GSK’s share price has been little changed following the announcement, having inched 0.11 percent higher to 1,388.50p as of 08:17 BST. The shares are slightly outperforming the benchmark FTSE 100 index which has slipped marginally into negative territory this morning.
The blue-chip drugmaker announced in a statement today that the FDA’s Pulmonary Allergy Drugs Advisory Committee had recommended the approval of GSK’s mepolizumab drug as an add-on maintenance treatment for severe asthma with eosinophilic inflammation, with eosinophils being a type of white blood cell. The committee, however, voted against the approval of the therapy in adolescents aged between 12 and 17, arguing that the efficacy and safety of the compound had not been adequately demonstrated, primarily on account of the limited number of patients in that age group.
The FDA is not obliged to follow the recommendations of its advisory committees but typically does so. GSK noted in today’s statement that regulatory filings for mepolizumab were underway in a number of other countries, including the EU and Japan, with further submissions planned during the course of the year. The FTSE 100 pharma group has high hopes for the compound, which is also being tested for other conditions, including chronic obstructive pulmonary disease (COPD) and eosinophilic granulomatosis with polyangiitis (EGPA), a rare disease formerly known as Churg-Strauss syndrome, which is characterised by widespread inflammation of small blood vessels.
Respiratory drugs are one of GSK’s key areas with the company expecting total sales of its respiratory portfolio to return to growth next year.
As of 09:14 BST, Friday, 12 June, GlaxoSmithKline plc share price is 1,385.75p.

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