J&J’s nipocalimab gains FDA fast track status for FNAIT risk reduction

2024-03-27

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J&J’s nipocalimab gains FDA fast track status for FNAIT risk reduction

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来源: Pharmaceutical Technology

Foetal and neonatal alloimmune thrombocytopenia causes the immune system of a pregnant individual to mistakenly target the platelets of the foetus. Credit: Africa Studio / Shutterstock.com.

Johnson & Johnson (J&J) has obtained fast track designation from the US Food and Drug Administration (FDA) for its nipocalimab to reduce foetal and neonatal alloimmune thrombocytopenia (FNAIT) risk in alloimmunised pregnant adults.

The designation aims to expedite the development and review of drugs targeting serious conditions with unmet medical needs.

This status also encourages frequent communication between the regulator and the treatment sponsor, in a bid to swiftly deliver new treatments to patients.

A serious and rare condition, FNAIT causes the immune system of a pregnant individual to mistakenly target the platelets of the foetus, leading to potential bleeding and clotting issues.

Nipocalimab is a fully human monoclonal antibody designed to reduce the levels of circulating immunoglobulin G (IgG) antibodies.

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It is said to be the only therapy currently in clinical development to meet the requirements for alloimmunised pregnant individuals with FNAIT risk.

Nipocalimab was awarded orphan drug designation by the FDA for its application in FNAIT In December 2023.

Nipocalimab is also being investigated for its use in haemolytic disease of the foetus and newborn (HDFN), another alloimmune condition of pregnancy.

Following promising Phase II safety and efficacy data from the UNITY clinical trial, the company is advancing nipocalimab into Phase III trials for HDFN.

J&J vice-president and autoantibody and maternal foetal immunology disease area leader Katie Abouzahr stated: “Receiving fast track designation for nipocalimab in FNAIT underscores the urgency to address the unmet need for safe, effective, and targeted treatments to prevent FNAIT, a condition that could carry severe health consequences and even be fatal for the foetus or newborn.

“We are committed to applying our decades of immunology leadership to pioneer innovative approaches to transform treatment for patients and their families affected by FNAIT and other alloantibody-driven diseases of pregnancy.”

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