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Rebinyn

Generic name: coagulation factor IX (recombinant), glycopegylated
Treatment for: Hemophilia B

FDA Advisory Committee Discusses Biologics License Application (BLA) for Nonacog Beta Pegol for the Treatment of People with Hemophilia B

PLAINSBORO, N.J., April 4, 2017 – Novo Nordisk today announced that the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration (FDA) met to discuss the data submitted to support the Biologics License Application (BLA) for nonacog beta pegol, an investigational glycoPEGylated extended-half-life recombinant factor IX product, for the treatment of hemophilia B.

The Committee reviewed the nonacog beta pegol data package, which included non-clinical studies, including toxicology, as well as data from clinical trials of nonacog beta pegol, including the paradigm™ Phase 3 clinical trial program involving 105 previously treated patients with severe or moderately severe hemophilia B. The Committee discussed the overall strengths and weaknesses of the application but was not asked to vote on a recommendation for approval of nonacog beta pegol.

“Novo Nordisk is committed to addressing the serious unmet medical needs of the hemophilia community and to delivering safe and effective medicines to patients,” said Stephanie Seremetis, M.D., Chief Medical Officer and Corporate Vice President of Hemophilia at Novo Nordisk. “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's feedback will be considered by the FDA in its review of the BLA for nonacog beta pegol. The FDA is not bound by the Committee's guidance, but takes its advice into consideration when reviewing investigational medicines.

The BLA for nonacog beta pegol was submitted to the FDA in May 2016 under the FDA's Prescription Drug User Fee Act V (PDUFA V) regulation. In Europe, nonacog beta pegol received a positive Committee for Medicinal Products for Human Use (CHMP) opinion on March 23, 2017.

About Advisory Committee Meetings

FDA advisory committees are panels of independent experts who advise the FDA on specific questions raised by the FDA as they consider regulatory decisions. The FDA is not bound by the committee's recommendation, but it takes its advice into consideration when reviewing new drug applications. According to the FDA Amendment Act of 2007 (FDAAA), the FDA should refer new drugs to an advisory committee meeting, or alternatively justify why an advisory committee meeting was not requested.

About Nonacog Beta Pegol

Nonacog beta pegol is a factor IX molecule with an extended half-life intended for replacement therapy in patients with hemophilia B. GlycoPEGylation is a well-established technique commonly used to prolong the circulating half-life of drugs.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.

Source: Novo Nordisk

Posted: April 2017

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