Kedrion Biopharma Extends Contract Manufacturing Agreement (CMA) for GAMMAKED in the US, Ensuring Availability to Patients

• Kedrion Biopharma will continue to market and distribute GAMMAKED in the U.S. through end of 2025
• GAMMAKED™ is an immune globulin injection FDA-approved to treat the rare conditions PI, ITP, and CIDP and has been approved and available in the U.S. since 2011
• CMA extension ensures that GAMMAKED will remain available without interruption to patients who rely on IG therapy

Fort Lee, NJ (February 15, 2022) – Kedrion Biopharma, an international biopharmaceutical company, specialized in the manufacture and distribution of plasma-derived therapeutic products used in treating rare and serious diseases, has extended its Contract Manufacturing Agreement, or CMA, with Grifols to market and distribute GAMMAKED through 2025.

GAMMAKED is an immune globulin (IG) injection for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults, primary humoral immunodeficiency (PI) in patients 2 years of age and older, and idiopathic thrombocytopenic purpura (ITP) in adults and children.

GAMMAKED became available in the U.S. in 2011, when Kedrion Biopharma first entered into a Contract Manufacturing Agreement (CMA) with Grifols. Since then, Kedrion has managed the marketing and distribution of GAMMAKED, extending the agreement in 2018 to 2023, and most recently on December 18, 2021, signed an amendment extending it to 2025.

“At Kedrion Biopharma, it is our mission to improve the lives of people with rare diseases,” said Giorgio Masetti, Kedrion Biopharma VP, Regional Commercial Director-US. “For people with these conditions, it can take years to reach a diagnosis and find treatment,” Masetti added. “Ensuring that patients have uninterrupted access to the treatments they depend on after such a long road is critical to us in fulfilling our responsibilities to patients.

About GAMMAKED™
INDICATIONS AND USAGE
GAMMAKED™ [Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified] is an immune globulin injection that is used to treat primary humoral immunodeficiency (PI) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS:

Do not use GAMMAKED if:

You have a history of severe allergic reactions to human immune globulin. Tell your healthcare provider if you have had a serious reaction to other medicines that contain human immune globulin. Ask if you are not sure.

You have an immunoglobulin A (IgA) deficiency and have antibodies to IgA and have a history of allergic reactions. Tell your healthcare provider if you have an IgA deficiency or ask if you are not sure.

WARNINGS AND PRECAUTIONS:
Severe allergic reactions may occur with IGIV products, including GAMMAKED. IgA deficient patients who have antibodies against IgA are at greater risk of developing severe allergic reactions. Your healthcare provider should have medications, such as epinephrine, to immediately treat any sudden severe allergic reactions.

If you are receiving GAMMAKED, you could experience higher than normal levels of protein in your blood, thick blood, or low sodium (salt) in your blood. This may prevent your blood from flowing easily and possibly lead to blood clots.

Brain inflammation or brain swelling called Aseptic Meningitis Syndrome (AMS) may occur infrequently with IGIV products, including GAMMAKED, especially if you receive a high dose or a rapid infusion.

Blood damage called hemolysis and hemolytic anemia can develop after treatment with GAMMAKED. Your healthcare provider will closely monitor you for signs and symptoms of hemolysis and hemolytic anemia.

Swelling of the lungs may occur in patients following IGIV treatment, including GAMMAKED. Your healthcare provider will monitor you for signs of lung damage (also known as transfusion-related acute lung injury [TRALI]).

GAMMAKED is made from human blood and, therefore, carries a risk of transmitting infectious agents, such as viruses, the agent of the variant Creutzfeldt-Jakob disease (vCJD), or unknown infectious agents. You should consult with your healthcare provider if you have any questions or concerns.

Be sure to tell your healthcare provider about your recent history of vaccinations. Live vaccines for diseases like measles, mumps, rubella and varicella may not work as well for you while you are receiving GAMMAKED. Tell your healthcare provider that you are taking GAMMAKED before you receive any vaccination.

ADVERSE REACTIONS:
To report SUSPECTED ADVERSE REACTIONS, contact KEDRION at 1-855-427-6378 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Please see GAMMAKED full Prescribing Information for complete prescribing details. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Kedrion Biopharma
Kedrion Biopharma is a leading international biopharmaceutical company that specializes in the development, production, and distribution of plasma-derived therapeutic products for use in treating serious diseases, disorders, and conditions such as immune system deficiencies and coagulation disorders. Kedrion has special expertise in the treatment of rare diseases and in the manufacture of hyper-immune products such as anti-hepatitis B, anti-tetanus and RhoGAM® for prophylaxis against Rh sensitization and subsequent hemolytic disease of the fetus and newborn. The company operates through a fully integrated business model from the collection of plasma in its own centers in North America to fractionation and production in its manufacturing facilities located in Italy, Hungary, and North America.

Headquartered in Castelvecchio Pascoli (Italy), Kedrion has over 2,700 employees and a commercial presence in approximately 100 countries worldwide. Kedrion places a high value on the welfare of those who benefit from its products, as well as on the people and the communities it serves. Additional information about Kedrion Biopharma can be found at kedrion.com and kedrion.us.

#



error: Content is protected !!