The treatment landscape for hemolytic disease of the fetus and newborn (HDFN) is constantly evolving, and it can be confusing, especially for those who are not part of the medical community.
To help, here is a guide to the current treatments and therapies available and in development for HDFN.
Current treatments
Currently, HDFN is typically treated with intravenous immunoglobulin and plasmapheresis. In addition, intrauterine transfusions may be performed when fetal anemia is detected.
After birth, the baby may require phototherapy and exchange transfusions in cases of high bilirubin caused by the breakdown of RBCs.
Read more about HDFN testing and diagnosis
While most cases of HDFN can have good outcomes when diagnosed early during pregnancy, scientists are currently developing a therapy known as nipocalimab that may be effective in treating HDFN with a superior safety profile compared to standard-of-care.
Nipocalimab
Nipocalimab is currently the only experimental therapy that is being investigated for use in HDFN, according to a press release published by Johnson & Johnson (J&J).
Developed by J&J, nipocalimab was granted FDA Breakthrough Therapy Designation in 2024 to treat alloimmunized pregnant women who are at a high risk of severe HDFN.
This approval was based on a phase 2 study that showed that the majority of patients who were administered nipocalimab had a live birth at gestational age of 32 weeks or after without needing intrauterine transfusions throughout pregnancy. In addition, this therapy was associated with low levels of severe adverse events.
Currently, this therapy is being studied in a global, double-blind, phase 3 trial assessing its use in pregnancies at risk of severe HDFN. This trial will further establish facts surrounding nipocalimab’s safety and efficacy.
It is important to distinguish that, unlike some rare disorders in which robust treatment is lacking, current protocol for treating HDFN has a fair success rate, especially when initiated early during antenatal care. The best way to protect against HDFN is to ensure that diagnosis is initiated early; this can best be achieved with close coordination with an obstetrician during the pregnancy period.
Sign up here to get the latest news, perspectives and information about HDFN sent directly to your inbox. Registration is free and only takes a minute.
