Mapping Strategies to Meet Substantial Unmet Rh immunization Treatment Needs Around World
· On February 5, 2018, Kedrion Biopharma and Columbia University Irving Medical Center jointly hosted a distinguished panel of pioneering scientists, physicians, the first mother to receive Rho (D) Immune Globulin, and others in celebration of the 50th anniversary of FDA approval of Rho(D) Immune Globulin, brand named RhoGAM®.
· RhoGAM is used to prevent Rh immunization in pregnant women who are Rh negative, a condition that can lead to hemolytic disease of the fetus and newborn (HDFN). HDFN is often fatal to a fetus or newborn. RhoGAM is given during and following pregnancy.
· Prior to 1968, approximately 10,000 U.S. infants succumbed to HDFN each year.
· After FDA approval of Rho (D) Immune Globulin in April 1968, and its subsequent commercialization in the early 1970s, the threat of HDFN’s effects on unborn and newborn children rapidly diminished in the U.S.
· Where effective RhIG protocols do not currently exist, as many as 14 percent of affected fetuses are stillborn and 50 percent of live births result in neonatal death or brain injury.
· Going forward, as a world leader in the treatment of Rh immunization, Kedrion Biopharma is committed to driving efforts aimed at solving acute unmet needs for Rh immunization treatment which can lead to HDFN in areas of the world where they still exist.
Fort Lee, NJ – February 12, 2018 – One of the most dramatic achievements of 20th century medicine – the 1968 discovery and subsequent U.S. Food and Drug Administration approval of RHo (D) immune globulin (RhIG), later marketed as RhoGAM – was the focus of a day-long celebration in New York City on February 5, 2018.
RhIG, which was developed at Columbia University Irving Medical Center, is a prescription medicine used in preventing Rh immunization in pregnant women who are Rh negative, a condition that can lead to hemolytic disease of the fetus and newborn (HDFN). HDFN is often fatal to a fetus or newborn. It can also result in miscarriage, stillbirth, early post-natal death and life-long disabilities in surviving babies.
Though no longer considered a threat to unborn children in many countries, HDFN does remain a dire public health issue in large parts of the world. Therefore, participants in the February 5th Celebration also began the process of mapping a global strategy to address this.
Jointly sponsored by Kedrion Biopharma and Columbia University Irving Medical Center (CUIMC), the February 5 event featured a panel of distinguished pioneering scientists and physicians, each of whom played a pivotal role in the development of RhIG. The panel also featured the first woman in the world to receive RhIG, and to then deliver a healthy child. Paolo Marcucci, Chief Executive Officer of Kedrion Biopharma and Lee Goldman, M.D., Executive Vice President and Dean of the Faculties of Health Sciences and Medicine, and Chief Executive of Columbia University Irving Medical Center, delivered remarks.
A Dark Legacy of Neonatal Complications Gives Way to Hope for Pregnant Women
Prior to 1968, HDFN claimed some 10,000 infant lives a year in the U.S. alone. The U.S. FDA approved RhIG in April of that year. Dr. Vincent Freda, an obstetrician, and Dr. John Gorman, the Director of the Blood Bank, both at Columbia, conducted pioneering research that led to a breakthrough in disease prophylaxis (RhoGAM®), effectively eradicating hemolytic disease of the newborn due to anti-Rh antibodies. In May, 1968, an expectant mother, Marianne Cummins, of Teaneck, NJ, received the first approved RhIG treatment, eventually giving birth to a healthy boy.
By the 1970s, routine antenatal care for mothers in the U.S. and U.K. included screening of all expectant mothers to find those whose pregnancy may be at risk of HDFN, and giving preventative treatment accordingly. Such steps have led to a dramatic decrease in the incidence of HDFN in these geographies and others, and, in particular, in the number of severe cases of the type once responsible for stillbirth and neonatal death. Today, few cases of HDFN due to anti-D are reported each year in the U.S., and RhIG is considered the standard of care for its prevention across North America, Europe, and Australia, the panel noted.
The February 5 panel members noted, however, that in countries where effective RhIG protocols do not currently exist, as many as 14 percent of affected fetuses are stillborn and 50 percent of live births result in neonatal death or brain injury. Further, although RhIG is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system, many of the countries where RhIG is most needed lack the appropriate healthcare delivery systems, appropriately skilled medical personnel, and the medical education and clinical training and other resources needed to enact such protocols.
“Today marks an exciting milestone exemplifying the kind of tremendous advances that can be achieved for the betterment of our world when science, medicine, and industry join forces to solve complex healthcare challenges,” said Paolo Marcucci, Chief Executive Officer of Kedrion Biopharma. “We at Kedrion Biopharma are extremely proud of the contributions we have made in this regard. As it relates to hemolytic disease of the fetus and newborn, the view ahead should be bright for all women, their partners, and their families around the globe. We look forward to continuing to play a key role in bridging to that future, beginning right here and now, with the additional support and collaboration of like-minded partners around the world.”
Bridging to the Future for Mothers, Children, and Families: HDFN Treatment in R-O-W
The February 5 panel identified several areas where focus is now needed in order to bring HDFN treatment to areas of the world where it is needed. Next steps include pinpointing geographies where an immediate and positive impact can be achieved, and working with other groups and coalitions that may also be in positions to combine resources to assist.
A taped recording of the February 5th, 2018 event can be found here.
About RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)]
Important Safety Information
RhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (300 μg) and MICRhoGAM® Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] (50 μg) are indicated for the prevention of Rh immunization, including during and after pregnancy and other obstetrical conditions or incompatible transfusion of Rh-positive blood.
RhoGAM® and MICRhoGAM® 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.
RhoGAM® and MICRhoGAM® contain a small quantity of IgA and physicians must weigh the benefit against the potential risks of hypersensitivity reactions. Hypersensitivity reactions include hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. 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.
You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/Safety/MedWatch/ or call 1-800-FDA-1088. Click here for the RhoGAM Full Prescribing Information
50th Anniversary of U.S. Approval of RhoGAM® Press Release RH-0572-00-2018