Japan Approves Prolacta Bioscience's Human Milk-Based Fortifiers as Prescription Medication

A Breakthrough in Neonatal Care: Japan's Approval of Prolacta Bioscience's Fortifiers

Prolacta Bioscience® is celebrating a significant milestone as Japan’s Ministry of Health, Labour, and Welfare (MHLW) grants approval for its exclusive enteral solution, PreemieFort®. This groundbreaking decision marks the first time fortifiers made entirely from human milk have been recognized as a prescription medication for vulnerable infants in neonatal intensive care units (NICUs).

Background of the Approval

The MHLW has designated PreemieFort® specifically for infants who weigh very little at birth, those with congenital gastrointestinal disorders or congenital heart defects, and infants recovering from gastrointestinal surgery. The move underscores Japan’s commitment to enhancing neonatal care, given its reputation for having one of the highest survival rates for premature infants and the lowest incidence of necrotizing enterocolitis (NEC), a severe intestinal disease that predominantly affects premature babies.

Both PreemieFort Enteral Solution 6 and PreemieFort Enteral Solution 8, marketed under the brand name “Humavant” outside of Japan, provide essential nutrition that helps support growth. They do so while maintaining the superior bioactivity levels found in human breast milk, crucial for the health of these fragile patients.

Clinical Studies and Evidence

The approval was bolstered by comprehensive clinical research conducted through the JASMINE trial, a randomized control study evaluating the growth and safety of exclusively human milk diets for infants with very low birth weights. The findings from this phase III trial provided critical evidence demonstrating that infants using Prolacta's fortifiers exhibited significantly enhanced growth, with no associated increase in morbidity or mortality.

Scott Elster, CEO of Prolacta Bioscience, articulated the importance of this milestone, stating, "The approval reflects the strength of clinical evidence and pharmaceutical-grade processing that meets Japan's stringent regulatory and quality standards." This reinforces the essential role human milk-based fortifiers play in neonatal health and sets a high benchmark for care across NICUs worldwide.

Trust in Human Milk Fortifiers

This decision not only affirms the nutritional value of Prolacta’s products but also signifies a clinical endorsement, helping healthcare providers select dietary options for their most vulnerable patients. Dr. Kate Tauber, a pediatric professor and director of the Human Milk Program at a prominent children’s hospital, expressed, “In the NICU, the nutrition we provide can influence the entire life trajectory of our patients.”

The approval encompassed three PreemieFort products, designed to provide concentrated nutrition, ensuring that infants receive vital nutrients while maximizing the protective qualities of human milk.

Commitment to Quality and Safety

Prolacta maintains industry-leading standards in the selection, analysis, and processing of donor milk, ensuring quality and safety remain uncompromised. These stringent procedures have paved the way for achieving this crucial pharmaceutical approval in Japan, which holds one of the strictest regulatory environments in the world.

The company's dedication to quality assurance not only safeguards vulnerable infants but promotes better outcomes across the board.

Conclusion

The approval of Prolacta’s human milk fortifiers in Japan signifies a landmark advancement in neonatal care and the growing recognition of the vital role that human milk plays in infant health. With this pioneering move, Japan establishes a precedent that may well influence neonatal care practices globally, providing new hope for many infants in NICUs around the world.

For more information on Prolacta Bioscience and its groundbreaking products, check their social media channels or their website, where they highlight their commitment to improving the health of premature infants.