ONIVYDE® Obtains U.S. FDA Approval of its Supplemental New Drug ApplicationFeb 15, 2024

PharmaEngine, Inc. (TWO:4162) announces strategic partner, IPSEN (Euronext: IPN; ADR: IPSEY), obtained supplemental New Drug Application (sNDA) approval from the U.S. FDA for ONIVYDE® regimen in first-line metastatic pancreatic ductal adenocarcinoma on February 13, 2024.

According to the World Health Organization (WHO) Cancer Today data, globally in 2022, there were 510,570 patients with initial diagnosis of pancreatic cancer and 466,983 patients' cause of death was pancreatic cancer.

Read more: Ipsen’s Onivyde® regimen, a potential new standard-of-care first-line therapy in metastatic pancreatic adenocarcinoma, approved by FDA