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).
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.
SEPTEMBER 8, 2018