GSK says USFDA wants more information on pulmonary drug
LONDON: GlaxoSmithKline (GSK) said 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.
(Writing by William Schomberg; Editing by Leslie Adler)
Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers. Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd