FDA panel reviews license application for potential hemophilia B treatment
The U.S. Food and Drug Administration (FDA) Blood Products Advisory Committee (BPAC) recently discussed nonacog beta pegol, a new treatment for hemophilia B, Novo Nordisk said in release.
The committee reviewed a package that was submitted to support the Biologics License Application (BLA) for the investigational glycoPEGylated extended-half-life recombinant factor IX product. The package included non-clinical studies and clinical trials, including the information provided by the Phase III clinical trial, the release said.
“Novo Nordisk is committed to addressing the serious unmet medical needs of the hemophilia community and to delivering safe and effective medicines to patients,” Novo Nordisk Chief Medical Officer and Corporate Vice President of Hemophilia Stephanie Seremetis said in the release. “We are encouraged by today’s discussion and look forward to working with the FDA to bring nonacog beta pegol to people with hemophilia B who may benefit from the protection of sustained, high factor IX activity in a once-weekly dose.”
The committee did not vote on a recommendation for nonacog beta pegol. Its feedback will be considered when the FDA reviews the medication for the BLA. The application was submitted in May 2016. Nonacog beta pegol received a positive opinion from the European Union (EU) Committee for Medicinal Products for Home Use (CHMP) on March 23.
Organizations in this story
Novo Nordisk Inc. 800 Scudders Mill Rd Plainsboro, NJ 08536
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903