Johnson & Johnson Gets FDA Fast-Track for Rare Pregnancy-Related Disease

By Dean Seal

Johnson & Johnson said the Food and Drug Administration has granted fast-track designation to its treatment for pregnant patients with fetal neonatal alloimmune thrombocytopenia.

The company is developing nipocalimab to reduce the risk of the rare and severe condition, which occurs when a pregnant woman's immune system mistakenly attacks platelets in a developing fetus, potentially posing a significant risk to the fetus or newborn.

The FDA's fast-track designation facilitates development and expedites the review of drugs that treat serious or life-threatening conditions and fill unmet medical needs.

Last December, nipocalimab was granted orphan drug designation, the FDA's special status given to drugs that show promise for potentially treating rare, or orphan, diseases that have fewer than 200,000 cases a year in the U.S.

Write to Dean Seal at [e-mail]

(END) Dow Jones Newswires

03-26-24 0838ET