Japan Approves Prolacta Bioscience's Human Milk-Based Supplements as Prescription Medicine

A Groundbreaking Breakthrough in Neonatal Care

In a major advancement for neonatal health, Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted prescription medicine status to PreemieFort®, a 100% human milk-based fortifier from Prolacta Bioscience. This approval marks a pivotal moment for the treatment of vulnerable infants, particularly those with very low birth weights or congenital gastrointestinal and cardiac disorders. Additionally, it aids those recovering from gastrointestinal surgeries. This crucial development came about through collaboration with Clinigen Group, who holds the marketing authorization and distributes the product in Japan. Outside the U.S., Canada, and Japan, PreemieFort is marketed under the name 'Humavant'.

This historic decision by the Japanese government underscores the essential role that 100% human milk fortifiers, like those developed by Prolacta, play in the health of the most fragile infants globally. According to Scott Elster, CEO of Prolacta Bioscience, the approval is a testament to solid clinical evidence supporting the pharmaceutical quality treatment that meets Japan's stringent regulatory requirements. The pivotal clinical trial, named JASMINE, provided foundational data for the rigorous review conducted by Japan's world-renowned Pharmaceuticals and Medical Devices Agency (PMDA).

The JASMINE study was a multicenter, phase III clinical trial that assessed the growth and safety associated with Prolacta’s human milk-based fortifiers. The results indicated significantly improved growth in low birth weight infants without increasing morbidity or mortality risks. Japan is already recognized as a global leader in neonatal care, boasting some of the highest survival rates for premature infants and some of the lowest rates of necrotizing enterocolitis (NEC)—a serious intestinal condition primarily affecting premature babies. By granting pharmaceutical approval to PreemieFort, Japan not only recognizes the nutritional advantages of Prolacta’s products but validates their status as medication in neonatal intensive care units (NICUs).

The approval extends to three Prolacta products: PreemieFort Enteral Solution 6 and 8, as well as PreemieFort Enteral Solution CF, all designed to provide concentrated nutrition aimed at supporting growth. These products deliver essential calories and nutrients while maintaining the highest bioactivity levels of human milk.

Such regulation underscores the commitment to improving outcomes for vulnerable infants with complex nutritional needs. According to Dr. Kate Tauber, a pediatric expert, the nutrition provided to the smallest patients significantly influences their lifelong health. The human milk-based fortifiers should adhere to the same rigorous standards as other medical therapies, ensuring they are consistent, controlled, and safe. Prolacta's dedication to quality pharmaceutical manufacturing safeguards the welfare of fragile infants, thus improving their health outcomes over time.

Prolacta upholds the industry's highest standards concerning donor milk selection, analysis, and processing—requirements that extend to the manufacturing of pharmaceutical-grade products. This commitment facilitated the recent prescription medicine approval in Japan, one of the most stringent regulatory environments worldwide.

About Prolacta Bioscience

Prolacta Bioscience® leads in human milk nutrition, dedicated to enhancing the health of critically ill and premature infants. The company’s human milk fortifiers and formulas have benefited over 125,000 vulnerable preemies globally. The historic approval of Prolacta’s PreemieFort® as prescription medicine in Japan not only reflects the firm’s unwavering commitment to quality and safety but also showcases the importance of human milk-based nutrition as a crucial treatment modality for infants in need. With over 20 donor milk screening tests and vat pasteurization processes used to ensure pathogen inactivation, Prolacta effectively preserves the bioactive components of human milk which are essential for immune protection, intestinal development, and overall growth. Prolacta has cultivated a secure and independent milk supply chain through long-term partnerships with selected donor mothers, ensuring adequate supply to meet NICU demands. The company’s product benefits have been substantiated in over 30 peer-reviewed clinical studies, highlighting the short- and long-term health advantages of its human milk-based fortifiers and formulas.