Benzinga | Jul 28, 2020 07:19AM EDT

Momenta Pharmaceuticals Announces FDA Rare Pediatric Disease Designation For Nipocalimab In HDFN

CAMBRIDGE, Mass., July 28, 2020 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NASDAQ:MNTA) today announced that its novel drug candidate, nipocalimab, has received rare pediatric disease designation from the U.S. Food and Drug Administration (FDA) for the prevention of hemolytic disease of the fetus and newborn (HDFN). Additionally, FDA granted nipocalimab orphan drug designation in HDFN. HDFN is a serious blood disorder in a fetus or newborn that occurs when red blood cell incompatibility exists between the blood types of a mother and fetus in utero.

"In HDFN, a mismatch in parent's blood group antigens causes the mother's immune system to recognize the fetus' red blood cells as foreign. This results in the development of pathogenic antibodies that transfer across the placenta during pregnancy and attack the baby's red blood cells causing fetal anemia which can be fatal," said Santiago Arroyo, M.D., Ph.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. "The standard treatment for HDFN involves intrauterine blood transfusions which are invasive and can be associated with significant complications, including in some cases fetal mortality. Receiving this designation emphasizes the need for a non-invasive, safe, and effective treatment option. Our trial in this indication is progressing and we are committed to working with the FDA to bring this option to families who experience this devastating disease as soon as possible."

Rare pediatric disease designation is granted by the FDA to drug candidates addressing serious or life-threatening diseases or conditions that affect fewer than 200,000 children in the U.S. Under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product. For more information about the rare pediatric disease program, please visit the FDA website at www.fda.gov.