Japan’s Ministry of Health, Labour and Welfare (MHLW) Approves PreemieFort® Enteral Solution as Prescription Medicine in the NICU
Prolacta Bioscience® today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved PreemieFort® Enteral Solution, a 100% human milk-based fortifier, as a prescription drug for very low birth weight infants, infants with congenital gastrointestinal disorders or congenital heart diseases, and those recovering from gastrointestinal surgery. This regulatory milestone was achieved in partnership with the Clinigen Group, which serves as Marketing Authorization Holder and distributor in Japan. PreemieFort is currently marketed under the brand name “Humavant” outside of the U.S., Canada, and Japan.
The landmark regulatory decision validates the critical role of Prolacta’s 100% human milk-based fortifiers for the most fragile infants and sets a powerful precedent for neonatal intensive care units (NICUs) worldwide.
“Japan’s approval of PreemieFort as a prescription drug reflects the strength of the clinical evidence and the pharmaceutical grade processing that stands up to the rigor of Japan’s stringent regulatory and quality requirements,” said Scott Elster, CEO of Prolacta Bioscience. ”The pivotal Japanese clinical study adds to the extensive evidence supporting the benefits of Prolacta’s exclusive human milk-based diet for critically ill and fragile premature infants.”
Clinical evidence generated in Japan from the JASMINE trial (“A Randomized, Controlled Study to Assess Growth and Safety of the Exclusive Human Milk Diet (EHMD) in Very Low Birth Weight (VLBW) Infants”) informed Japan’s world-class Pharmaceuticals and Medical Devices Agency’s (PMDA) review. The Japanese-led phase III, randomized, controlled, open-label, multicenter trial evaluated growth and safety associated with Prolacta’s 100% human milk-based fortifiers, demonstrating significantly better growth in VLBW infants with no change in morbidity or mortality.
Japan is recognized as a global leader in neonatal care, with among the highest preterm survival rates and lowest rates of necrotizing enterocolitis (NEC),1,2 a life-threatening intestinal disease primarily affecting premature infants. By granting pharmaceutical approval to PreemieFort, Japan is affirming that Prolacta’s human milk-based fortifiers, free from cow milk, are not simply a nutritional choice but an Rx medicine in the NICU.
Japan’s approval includes three Prolacta products — PreemieFort Enteral Solution 6, PreemieFort Enteral Solution 8 (Humavant+6 and Humavant+8 human milk-based fortifiers outside the U.S., Canada, and Japan), and PreemieFort Enteral Solution CF (Humavant CR human milk caloric fortifier outside the U.S., Canada, and Japan) — which provide concentrated nutrition to support growth by delivering essential calories and nutrients, while retaining the highest level of human milk bioactivity.
The approval demonstrates clinical confidence in the benefits and safety of PreemieFort human milk-based fortifiers across a wider range of vulnerable infants with complex nutritional needs.
“In the NICU, what we feed our smallest patients can influence their entire life,” said Kate Tauber, MD, MA, professor of pediatrics and director of the Human Milk Program at Bernard and Millie Duker Children’s Hospital. “Human milk-based fortifiers should be held to the same expectations as other therapies, consistent, tightly controlled, and safe. Prolacta’s commitment to pharmaceutical-quality manufacturing requirements helps protect vulnerable infants and supports better outcomes.”
Prolacta maintains the industry’s strictest quality and safety standards for screening, testing, and processing donor milk — standards that extend through pharmaceutical grade product manufacturing. Together, these controls earned Japan’s prescription drug approval, one of the world’s highest regulatory benchmarks.
