LONDON: 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).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.