FDA Grants Orphan Drug Designation to Uttroside-B for Liver Cancer

The FDA has granted Orphan Drug Designation to Uttroside-B (Q Biomed Inc), a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. In preclinical studies, Uttroside-B was up to 10 times more potent against HCC cells than sorafenib, the standard of care drug at the time, according to a press release.

Uttroside-B may benefit from a 7-year period of market exclusivity following marketing approval, grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits. Further, preclinical testing is now underway to support an FDA Investigational New Drug application expected this year.

"Orphan Drug Designation gives our Uttroside-B program a substantial boost, and we expect it will significantly accelerate development and reduce costs. We are pleased that the FDA recognizes the urgent need for effective treatments for HCC, and that the agency sees the potential of Uttroside-B to address this difficult to treat cancer," said Q BioMed CEO Denis Corin in the press release.

REFERENCE

Q BioMed’s Uttroside-B Receives U.S. FDA Orphan Drug Designation in the Treatment of Liver Cancer [email]. Sent January 27, 2021. Accessed January 27, 2021.