The FDA has Approved a breakthrough therapy designation for Johnson & Johnson’s Nipocalimab

The US FDA has given a breakthrough therapy designation to Johnson & Johnson’s nipocalimab. This recognition is for the treatment of pregnancies where the mother’s antibodies pose a potential increased risk of severe blood-related issues for the foetus and newborn, known as haemolytic disease.  

This experimental treatment is the sole one currently in clinical use for the condition, which arises when the mother and baby’s blood types are not compatible.  

Nipocalimab is an antibody that doesn’t activate immune responses and aims to lower the levels of certain antibodies in the bloodstream.  

The breakthrough therapy designation was authorized following a second stage study that assessed the risks, adverse effects, and absorption and distribution of the drug.  

Katie Abouzahr, Johnson & Johnson’s vice chief, stated, “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.”  

Abouzahr went on to add, “We are committed to addressing the substantial unmet need in this devastating disease.” 

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