Novo Nordisk launches ESPEROCT® in the U.S. for the treatment of people with hemophilia A

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

Important Safety Information

Who should not use Esperoct^®?

• 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

What is the most important information I need to know about Esperoct^®?

• 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

What should I tell my healthcare provider before using Esperoct^®?

• 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^®

What are the possible side effects of Esperoct^®?

• Common side effects of Esperoct^® include rash or itching, and swelling, pain, rash or redness at the location of infusion

Please see Prescribing Information at https://www.novo-pi.com/esperoct.pdf.

About Novo Nordisk
Novo Nordisk is a global healthcare company that’s been making innovative medicines to help people with diabetes lead longer, healthier lives for 95 years. This heritage has given us experience and capabilities that also enable us to help people defeat other serious diseases including obesity, hemophilia and growth disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term and do business in a financially, socially and environmentally responsible way. With U.S. headquarters in New Jersey and production and research facilities in six states, Novo Nordisk employs nearly 6,000 people throughout the country. For more information, visit novonordisk.us, Facebook, Instagram and Twitter.

Further information

_____________________

References

1. ESPEROCT^® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; October 2019.
2. Hemophilia Federation of America. Hemophilia A. Available at: https://www.hemophiliafed.org/understanding-bleeding-disorders/what-is-hemophilia/hemophilia-a/. Accessed December 2019.
3. National Hemophilia Foundation. Inhibitors & Other Complications. Available at: https://www.hemophilia.org/Bleeding-Disorders/Inhibitors-and-Other-Complications. Accessed December 2019.
4. National Hemophilia Foundation. Hemophilia A. Available at: https://www.hemophilia.org/Bleeding-Disorders/Types-of-Bleeding-Disorders/Hemophilia-A. Accessed December 2019.
5. Giangrande P, et al. Clinical evaluation of glycoPEGylated recombinant FVIII: Efficacy and safety in severe haemophilia A. Thromb Haemost 2017; 117(02): 252-261.

ESPEROCT^® is a registered trademark of Novo Nordisk A/S.

Novo Nordisk is a registered trademark of Novo Nordisk A/S.

© 2020 Novo Nordisk All rights reserved. US20ESP00022 February 2020