> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Novo Nordisk’s Esperoct Approved for Treating Hemophilia
- URL: https://www.fdaweb.com/novo-nordisks-esperoct-approved-for-treating-hemophilia/
- Published: 2019-02-19T12:00:00.000Z
- Updated: 2026-09-15T01:05:38.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143411

FDA has approved a Novo Nordisk BLA for Esperoct (turoctocog alfa pegol) for treating adults and children with hemophilia A. The therapy is indicated for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding.

Approval is based on data that showed Esperoct provides effective routine prophylaxis in people with severe hemophilia A, according to the company. “Furthermore, Esperoct was found to be efficacious in treatment and control of bleeding episodes and perioperative management,” it says. The drug’s overall safety profile is similar to what has been reported for other long-acting Factor VIII products, it adds.