GlaxoSmithKline: FDA Needs More Data to Approve Mepolizumab for COPD
September 10 2018 - 2:43AM
Dow Jones News
By Carlo Martuscelli
The U.S. Food and Drug Administration needs more clinical data
to support the approval of mepolizumab as an add-on treatment for
exacerbations in patients with chronic obstructive pulmonary
disease, GlaxoSmithKline PLC (GSK.LN) said Monday.
The company said it will work with the FDA to take the
appropriate next steps to secure an approval from the
regulator.
Mepolizumab was first approved in 2015 for patients with severe
asthma, and the U.K. pharmaceutical major is trying to widen its
prescription as a treatment for COPD.
Write to Carlo Martuscelli at carlo.martuscelli@dowjones.com
(END) Dow Jones Newswires
September 10, 2018 02:28 ET (06:28 GMT)
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