Kedrion Biopharma Inc. has begun the new year with acquiring the biologics license for RhoGAM® and MICRhoGAM® Ultra-Filtered PLUS Rho(D) Immune Globulin (Human). The FDA announced the license transfer to Kedrion in December 2014. The company acquired the two therapies from Ortho-Clinical Diagnostics (OCD) in 2012. It also acquired Somerset Laboratories, a plasma collection center in Williamsville, NY, dedicated to collecting the unique hyper-immune plasma used in the manufacture of RhoGAM®.
RhoGAM® is prescribed to prevent hemolytic disease of the fetus and newborn (HDFN) and has saved the lives of millions of babies since it was developed in 1968 (1). MICRhoGAM® is used in cases of actual or threatened pregnancy termination or in cases following exposure to small amounts of Rho(D) incompatible blood or blood products. Both RhoGAM® and MICRhoGAM® are made from human plasma, and all plasma-derived products may carry a risk of transmitting infectious agents.
OCD will continue to manufacture RhoGAM® and MICRhoGAM® until Kedrion’s own facility in Melville, NY, is authorized by the FDA for the manufacturing of these two products. All plasma used to make RhoGAM® and MICRhoGAM® will continue to come from the Somerset Labs.
Kedrion CEO, Paolo Marcucci noted, "Obtaining the FDA BLA for RhoGAM® Brand, the legacy anti-D immune globulin, is a milestone in consolidating our portfolio of high-quality plasma-derived products, including those for the treatment of hemophilia and immune deficiencies."
RhoGAM® and MICRhoGAM® are distributed around the world, pursuant to applicable marketing authorizations. License transfer was completed in Europe and is ongoing in many other countries. Kedrion will be expanding its education and marketing activities worldwide for the products.
Reference: 1. data on file. Kedrion Biopharma Inc.
Important Safety Information for RhoGAM® Brand
RhoGAM® (300ug) and MICRhoGAM® Ultra-Filtered PLUS (50ug) Rho(D) Immune Globulin (Human) are made from human plasma. Since all plasma-derived products are made from human blood, they may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakob disease (CJD) agent. RhoGAM® and MICRhoGAM® are intended for maternal administration. Do not inject the newborn infant. Local adverse reactions may include redness, swelling, and mild pain at the site of injection and a small number of patients have noted a slight elevation in temperature. Patients should be observed for at least 20 minutes after administration. Hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. RhoGAM® and MICRhoGAM® contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Patients who receive RhoGAM® and MICRhoGAM® for Rh incompatible transfusion should be monitored by clinical and laboratory means due to the risk of a hemolytic reaction.
Kedrion is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as hemophilia, immune system deficiencies and hemolytic disease of the fetus and newborn. Kedrion Biopharma Inc., the US subsidiary of Kedrion, is headquartered in Fort Lee, New Jersey.
Kedrion launched US operations in 2011, but the company’s international roots stretch back several decades in the production of blood and plasma-derived products. It places a high value not only on the welfare of those who benefit from its products but also on the people and communities where it operates.
Additional information about Kedrion Biopharma can be found at www.kedrion.us.