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Novo Nordisk Gets FDA Nod for Haemophilia Drug Esperoct

Zacks Equity Research

Novo Nordisk A/S NVO announced that the FDA has approved its biologics license application (BLA) for Esperoct (turoctocog alfa pegol, N8-GP) regarding the treatment of haemophilia A in adult patients and children.

The drug is approved for the routine prophylactic to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes plus perioperative management of bleeding in the given patient population.

Per the company, due to third-party intellectual property (IP) agreements, it will not be able to launch the drug before 2020 in the United States.

Last February, Novo Nordisk submitted the BLA for Esperoct to the FDA regarding treatment of people with haemophilia A and filed a marketing authorization application to the European Medicines Agency for the same. That is also under review in Japan.

The nod was based on data from the largest pre-registration clinical program conducted in haemophilia A including 270 previously treated people (PTPs) afflicted with the disease, having more than five years of clinical exposure.

Esperoct was effective in treating severe haemophilia A through a simple fixed dosing regimen of one injection every four days in adults and adolescents or every 3-4 days (twice-weekly) in children. The drug was also found to be efficacious in controlling bleeding episodes and perioperative management with no acute safety concerns.

Shares of Novo Nordisk have lost 2.4% in the past year versus the industry’s increase of 7.8%.

We would like to remind investors that in May 2017, Novo Nordisk received an FDA approval for its BLA related to Rebinyn (N9-GP) (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B. Rebinyn is the brand name for nonacog beta pegol, N9-GP, in the United States.

Meanwhile, last August, the FDA approved Bayer’s BAYRY Jivi (BAY94-9027) for the routine prophylactic treatment of hemophilia A in previously-treated adults and adolescents aged 12 years or above in the United States. The drug has also secured a nod for on-demand treatment and perioperative management of bleeding in the same patient population.

Jivi is a long acting PEGylated recombinant human Factor VIII (rFVIII) replacement therapy. The initial prophylactic regimen for Jivi is recommended twice weekly with the scope of dosing every five days and further, individually adjusting to less or more frequent dosing based on bleeding episodes.

Zacks Rank & Stocks to Consider

Novo Nordisk currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large cap pharma sector include Bristol-Myers Squibb Company BMY and GlaxoSmithKline plc GSK, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Bristol-Myers’ earnings estimates have been revised 2.2% upward for 2019 over the past 60 days. The stock has surged 37.2% so far this year.

GlaxoSmithKline’s earnings estimates have moved 3.2% north for 2019 over the past 90 days. The stock has gained 11% in a year.

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