GlaxoSmithKline share price: FDA panel backs asthma drug only for adults

on Mar 20, 2015
Updated: Oct 21, 2019

GlaxoSmithKline Plc (LON:GSK) and Theravance Inc (NASDAQ:THRX) won the backing of a panel of US regulatory advisers to expand the use of their respiratory drug Breo Ellipta to treat adult patients with asthma. The panel, however, did not back the use of the therapy in adolescents.

GlaxoSmithKline’s share price was little changed in yesterday’s session, adding 0.40 percent to close at 1,630p. The advance was largely in line with gains in the broader market, with the blue-chip FTSE 100 index closing 0.25 percent higher at 6,962.32 points.
GSK and Theravance announced in a joint statement last night that the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA) had voted that the two companies’ Breo Ellipta therapy should be approved for once daily treatment of asthma in adults 18 years and older. The panel, however, voted 19-1 that the data did not support approval for use in children aged 12 to 17 and recommended a large safety trial, similar to those being conducted for other drugs in the same class.
Breo Ellipta is an inhaled treatment which has already been approved to treat chronic obstructive pulmonary disease (COPD). GSK, however, is seeking approval of the drug for use in patients aged 12 years and older to help control their asthma. While the FDA is not obliged to follow the advice of its advisory panels, it typically does so.
Darrell Baker, head of GSK’s global respiratory franchise, said in the statement that the company’s aim was to work with the FDA and “answer any outstanding questions to enable them to make a fully informed decision”. The US regulator is expected to rule on whether to approve the drug by the end of next month.
As of 07:25 GMT, Friday, 20 March, GlaxoSmithKline plc share price is 1,630.00p.

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