HLB Receives FDA CRL for Rivoceranib NDA Over Manufacturing Issues

HLB received an FDA Complete Response Letter (CRL) for rivoceranib, citing manufacturing issues. (Photo courtesy of IT Times)

 

HLB said its U.S. subsidiary, Elevar Therapeutics, has received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) of rivoceranib, a treatment for unresectable hepatocellular carcinoma. The CRL is related to cGMP observations at Jiangsu Hengrui's manufacturing facility, not to the drug's clinical efficacy or safety.

The FDA did not request additional clinical trials or new efficacy and safety data. HLB said it will work with Jiangsu Hengrui to address the manufacturing issues and resubmit the NDA as soon as the facility meets FDA requirements.

IT Times: https://www.ittimes.com/news/articleView.html?idxno=85780

HLB Receives FDA CRL for Rivoceranib as Manufacturing Issues Delay Approval - IT타임스