Japan's Groundbreaking Approval for Human Milk Fortifiers in Neonatal Care

A Historical Milestone in Neonatal Care

In a monumental decision that marks a significant advancement in neonatal care, Japan's Ministry of Health, Labour and Welfare (MHLW) has officially approved the use of Prolacta Bioscience's PreemieFort Enteral Solution as a prescription medication. This groundbreaking approval pertains specifically to infants who are extremely low birth weight, those affected by congenital gastrointestinal disorders, congenital heart diseases, or those recovering from gastrointestinal surgeries. This is the first time that a 100% human milk-based fortifier has received such recognition, setting a new standard for neonatal intensive care units (NICUs) globally.

The Importance of Human Milk-Based Nutrition

Prolacta's commitment to improving health outcomes for critically ill and premature infants has led to the development of its human milk-based fortifiers. Unlike traditional fortifiers that may include cow's milk, PreemieFort is a pure, human product. According to Scott Elster, CEO of Prolacta Bioscience, this approval validates the essential role that human milk-based fortifiers play in the diets of the most vulnerable infants.

With rigorous testing and clinical evidence, Prolacta demonstrated through studies, including the significant JASMINE trial, that its fortifiers lead to better growth outcomes in very low-birth-weight infants without increasing morbidity or mortality rates. This data played a crucial role in the review process by Japan's Pharmaceuticals and Medical Devices Agency (PMDA).

A New Paradigm in Neonatal Care

Japan is internationally recognized for its high preterm survival rates and the low incidence of necrotizing enterocolitis (NEC) in infants. By acknowledging PreemieFort as a prescription drug, Japan emphasizes the importance of high-quality, tailored nutrition for fragile infants in NICU settings. Alongside this, Prolacta's products maintain the highest safety and quality standards, ensuring that infants receive optimal care.

In addition to PreemieFort Enteral Solution, Japan's approval includes PreemieFort Enteral Solution 6 and PreemieFort Enteral Solution 8, which support the nutritional needs of these delicate patients by providing concentrated calories and essential nutrients while retaining the bioactive properties of human milk. This moves the conversation beyond mere nutrition and positions human milk fortifiers as part of a comprehensive medical strategy for infant care.

Supporting Fragile Infants

Healthcare professionals like Dr. Kate Tauber, a leading pediatrician, stress that what is given to the smallest patients is crucial for their development and long-term health outcomes. The expectation is not just that they are fed, but that they receive high-quality, safe, and effective nutrition. Prolacta's rigorous manufacturing processes ensure that every batch meets the highest pharmaceutical-grade standards.

Prolacta Bioscience has been a leader in human milk nutrition for many years, and with this latest approval, it solidifies its position in the global market. The company is dedicated to ensuring that thousands of infants benefit from its innovative products. With over 125,000 premature infants having received Prolacta's products worldwide, their impact on improving neonatal health is unprecedented.

Conclusion

Japan's approval of Prolacta's PreemieFort enters a new era for neonatal care where human milk-based nutrition is recognized not just as a choice, but as a treatment for some of the most vulnerable infants. This is expected to catalyze further advancements and discussions globally about the vital role of human milk in pediatric healthcare. As neonatal care continues to evolve, the focus will be on enhancing the standards of care and delivery to ensure every infant has the best possible start in life.