(Reuters) – Novartis AG said on Friday the U.S. Food and Drug Administration declined the approval of inclisiran, a potential treatment for adults who have elevated low-density cholesterol and are already on statins.
The FDA cannot approve the drug by the previous action date of Dec. 23 due to unresolved facility inspection-related conditions, the drugmaker said.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Anil D’Silva)
