Japan's Landmark Approval of Human Milk Fortifiers for Neonatal Care Revolutionizes Infant Nutrition

A Landmark Step in Neonatal Care

In a pioneering move, Japan’s Ministry of Health, Labour and Welfare (MHLW) has officially recognized Prolacta Bioscience's PreemieFort® Enteral Solution as a prescription drug, catering specifically to the needs of very low birth weight (VLBW) infants. This innovative formula, which is 100% human milk-based, signifies a monumental advancement in the realm of neonatal nutrition, specifically for vulnerable infants facing various health challenges.

Background and Significance

Prolacta Bioscience, based in Duarte, California, announced this significant approval on February 19, 2026. The decision came as a result of Prolacta's collaboration with the Clinigen Group, which serves as the Marketing Authorization Holder and distributor in Japan. This landmark decision underscores the vital role that human milk-based fortifiers play in the nutritional support of fragile infants, particularly those who are critically ill or recovering from surgery.

Clinical Evidence and Regulatory Milestones

The approval of PreemieFort leverages robust clinical evidence supported by a pivotal study conducted in Japan, known as the JASMINE trial. This rigorous phase III trial, which was randomized, controlled and multicenter, assessed the growth and safety associated with the exclusive human milk diet for VLBW infants. The results indicated a significant improvement in growth among infants receiving Prolacta’s fortifiers, without any adverse effects on morbidity or mortality rates.

This regulatory decision aligns with Japan’s reputation as a leader in neonatal care, characterized by some of the highest survival rates for premature infants and the lowest occurrences of necrotizing enterocolitis (NEC), a serious intestinal condition affecting preterm infants. By granting pharmaceutical status to PreemieFort, Japan acknowledges that these human milk-based products are not just dietary options but crucial therapeutic agents in neonatal intensive care units (NICUs).

Detailed Overview of Approved Products

Japan's approval encompasses three specific Prolacta products: PreemieFort Enteral Solution 6, PreemieFort Enteral Solution 8 (known as Humavant+6 and Humavant+8 outside Japan), and PreemieFort Enteral Solution CF (Humavant CR). These products are designed to provide concentrated nutrition to extremely vulnerable infants by delivering essential calories and nutrients, while maintaining the critical bioactivity of human milk.

Kate Tauber, MD, a professor of pediatrics at Bernard and Millie Duker Children’s Hospital, stated, “What we feed our smallest patients can influence their entire life. Human milk-based fortifiers should be subjected to the same high standards as other therapies to ensure their safety and efficacy.” Prolacta’s commitment to pharmaceutical-grade manufacturing emphasizes the importance of protecting these vulnerable infants, ultimately supporting better health outcomes.

Commitment to Quality and Safety

Prolacta sets the bar high by enforcing the strictest quality and safety standards throughout its donor milk screening and processing procedures. The approval from Japan's regulatory body reflects a comprehensive evaluation process, solidifying Prolacta’s manufacturing protocols as one of the highest benchmarks in the world.

As Prolacta continues to broaden its impact in the field of neonatal health, the company's innovations are already helping over 125,000 vulnerable premature infants globally. This recent regulatory milestone, marking the first prescription approval for a human milk-based product in Japan, opens up a new frontier in infant care, reinforcing the therapeutic potential of human milk for premature and medically fragile infants.

Conclusion

The approval of PreemieFort as a pharmaceutical solution reaffirms the invaluable role of human milk in nurturing the most vulnerable populations. As global leaders in neonatal care take a closer look at the implications of this approval, it has the potential to inspire similar initiatives worldwide, changing the landscape of infant nutrition and care on a global scale. With rigorous standards and scientific backing, Prolacta sets a precedent in how we approach neonatal nutrition, advocating for better outcomes for our youngest patients.