(Reuters) – The U.S. Food and Drug Administration (FDA) has declined approval for Eli Lilly and Co’s drug to treat a type of chronic inflammatory bowel disease in adults, the company said on Thursday.
The health regulator cited issues related to the proposed manufacturing of the drug, mirikizumab, with no concerns about the clinical data package, safety, or label for the medicine.
The company said it was confident in the drug’s late-stage data and was working with the FDA.
(Reporting by Raghav Mahobe, Bhanvi Satija and Sriparna Roy in Bengaluru; Editing by Rashmi Aich and Anil D’Silva)
