Novo Nordisk has announced the launch of ESPEROCT®, the company’s long-acting recombinant factor VIII product for the prevention and treatment of bleeding in individuals with hemophilia A. The new therapy is specifically indicated for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment, control of bleeding episodes and perioperative management of bleeding.
This announcement follows the U.S. Food and Drug Administration approval of a Biologics License Application for ESPEROCT® in 2019, which was based on a series of successful clinical trials designed to evaluate the safety and efficacy of the therapy in 270 previously treated patients with severe hemophilia A. Trial data showed that it provided effective routine prophylaxis in people with severe hemophilia A through a dosing regimen of one infusion every four days in adults and adolescents or every three-to-four days (twice-weekly) in children. The company also reported that ESPEROCT® was shown to be safe and well tolerated across all the clinical trials, with the most frequently reported adverse reactions (≥ 1%) being rash, redness, itching and injection site reactions.
“At Novo Nordisk, we have a longstanding commitment to the hemophilia community, beginning with the development of our first recombinant factor therapy more than 30 years ago,” said Pia D’ Urbano, Corporate Vice President, Biopharmaceuticals, Novo Nordisk Inc. “We recognize that people with rare bleeding disorders need multiple therapy options and are proud to now make ESPEROCT® available as a new treatment option for those living with hemophilia A, the most common form of the chronic bleeding disorder.”
Source: Novo Nordisk press release dated February 10, 2020