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


© Reuters. FILE PHOTO: The GSK logo is seen on top of GSK Asia House in Singapore

LONDON (Reuters) – GlaxoSmithKline (L:) 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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