GSK says U.S. FDA wants more information on pulmonary drug
Reuters
Published Sep 07, 2018 23:24
GSK says U.S. FDA wants more information on pulmonary drug
LONDON (Reuters) - GlaxoSmithKline (L:GSK) said on Friday that U.S. health authorities had asked for more information about its Nucala drug for use in combating chronic obstructive pulmonary disease (COPD).
GSK said it had received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its application for mepolizumab - the generic name for Nucala - as an add-on treatment to inhaled corticosteroid-based maintenance treatment.
"The CRL states that more clinical data are required to support an approval," the company said in a statement. "GSK will work closely with the FDA to determine the appropriate next steps for the supplementary biologics licence application."
The FDA has previously cleared Nucala to treat severe asthma.
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Written By: Reuters
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