GSK says U.S. FDA wants more information on pulmonary drug

LONDON (Reuters) – GlaxoSmithKline 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).

FILE PHOTO: The GlaxoSmithKline (GSK) logo. March 21, 2018. REUTERS/Loriene Perera/File Photo

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 license application.”

The FDA has previously cleared Nucala to treat severe asthma.

Writing by William Schomberg; Editing by Leslie Adler

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