Novo Nordisk launches ESPEROCT in the U.S. for the treatment of people with hemophilia A
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
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When used by adults every four days, ESPEROCT? can help reduce the frequency of bleeding with less frequent dosing
Plainsboro, N.J.,?February 10, 2020???Novo Nordisk announced today that ESPEROCT??[antihemophilic factor (recombinant), glycopegylated-exei] is now available in?the U.S.?for the treatment of adults and children with hemophilia A. ESPEROCT??is a recombinant extended half-life factor VIII replacement therapy used to prevent or reduce the number of bleeding episodes, to treat and control bleeding, and to manage bleeding during surgery in people with hemophilia A.1 ?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.? Hemophilia A is a chronic, inherited bleeding disorder, which affects nearly 20,000 people in the U.S. Hemophilia A is the most common form of hemophilia.2?People with hemophilia A have deficient factor VIII activity that interferes with blood clotting and results in prolonged or spontaneous bleeding.2?Bleeding episodes can be debilitating, as they often cause pain and can lead to chronic swelling, reduced mobility, and long-term joint damage.3?Approximately 60 percent of those living with hemophilia A have the severe form of the disorder.4 ESPEROCT??replaces the clotting Factor VIII that people with hemophilia A are missing.1?Compared to standard half-life treatments, which require multiple intravenous injections, ESPEROCT??helps people with hemophilia A maintain high Factor VIII levels longer, helping reduce frequency of bleeding with less frequent dosing.5? ESPEROCT??was approved by the U.S. Food and Drug Administration in 2019 based on the results from the largest and longest clinical trial program conducted in hemophilia A. The FDA approval of ESPEROCT??is based on data from five multinational trials, which included 270 patients.1?ESPEROCT??was shown to provide effective routine prophylaxis in people with severe hemophilia A through a fixed dosing regimen of one injection every 4 days in adults and adolescents or every 3-4 days (twice-weekly) in children. Across the clinical trials and age groups, ESPEROCT??was shown safe and well tolerated.1,5?The most frequently reported adverse reactions (= 1%) were rash, redness, itching and injection site reactions.1?ESPEROCT??is also available in Switzerland and Germany, with additional countries to follow. Novo Nordisk is committed to making ESPEROCT??accessible for all appropriate patients whose physicians have prescribed it. As part of this commitment, the company offers a patient assistance program called NovoSecure?, which allows eligible hemophilia patients who have been prescribed Novo Nordisk medicines to apply for product assistance. These individuals and their caregivers can get more information about Novo Nordisk?s product assistance programs by visiting NovoCare.com, Novosecure.com or calling 1-844-NOVOSEC (1-844-668-6732). To learn more about ESPEROCT??as a treatment option for hemophilia A, visit?Esperoct.com. What is Esperoct?? Esperoct??[antihemophilic factor (recombinant), glycopegylated-exei] is an injectable medicine to treat and prevent or reduce the number of bleeding episodes in people with hemophilia A. Your healthcare provider may give you Esperoct??when you have surgery- Esperoct??is not used to treat von Willebrand Disease
- You should not use Esperoct??if you are allergic to factor VIII or any of the other ingredients of Esperoct??or if you are allergic to hamster proteins
- Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center
- Call your healthcare provider right away or get emergency treatment right away if you get any signs of an allergic reaction, such as: hives, chest tightness, wheezing, dizziness, difficulty breathing, and/or swelling of the face
- Before taking Esperoct?, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non?prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII
- Your body can make antibodies called ?inhibitors? against Esperoct?, which may stop Esperoct??from working properly.?Call your healthcare provider right away if your bleeding does not stop after taking Esperoct?
- Common side effects of Esperoct??include rash or itching, and swelling, pain, rash or redness at the location of infusion
Media: | ||
Ken Inchausti | +1 609 240 9429 | kiau@novonordisk.com |
Investors: | ||
Kristoffer Berg | + 609 235 2989 | krdb@novonordisk.com |
- ESPEROCT??[package insert]. Plainsboro, NJ: Novo Nordisk Inc; October 2019.
- Hemophilia Federation of America. Hemophilia A. Available at:?https://www.hemophiliafed.org/understanding-bleeding-disorders/what-is-hemophilia/hemophilia-a/. Accessed December 2019.
- National Hemophilia Foundation. Inhibitors & Other Complications. Available at:?https://www.hemophilia.org/Bleeding-Disorders/Inhibitors-and-Other-Complications.?Accessed December 2019.
- National Hemophilia Foundation. Hemophilia A. Available at:?https://www.hemophilia.org/Bleeding-Disorders/Types-of-Bleeding-Disorders/Hemophilia-A. Accessed December 2019.
- Giangrande P, et al.?Clinical evaluation of glycoPEGylated recombinant FVIII: Efficacy and safety in severe haemophilia A.?Thromb Haemost?2017; 117(02): 252-261.