Johnson & Johnson, a United States-based multinational, pharmaceutical, and medical technologies corporation, announced on Friday that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its nipocalimab intended for the treatment of alloimmunised pregnant individuals at high risk of severe hemolytic disease of the foetus and newborn (HDFN).

Presently, the product is the only therapy reported to be in clinical development for the treatment of alloimmunised pregnant individuals at risk of severe HDFN.

The product has received Breakthrough Therapy Designation based on data from the proof-of-concept Phase two open-label UNITY clinical trial.

Katie Abouzahr, M.D., vice president, Autoantibody and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson, said, 'Nipocalimab represents a novel approach for the treatment of patients at risk of severe HDFN who need proven, safe, non-surgical solutions to help address the serious health consequences of this condition. We are committed to addressing the substantial unmet need in this devastating disease.'