Novo Nordisk Gets FDA Nod For Haemophilia Drug Esperoct
Zacks Investment Research | Feb 19, 2019 09:53PM ET
Novo Nordisk (CO:NOVOb) A/S (NYSE: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 Zacks Investment Research
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