#Japan #Tokyo #neonatal care #Prolacta Bioscience #PreemieFort

Japan's Groundbreaking Approval of Human Milk Fortifiers

In a monumental advancement for neonatal health, Japan's Ministry of Health, Labour and Welfare (MHLW) has officially approved Prolacta Bioscience’s PreemieFort® Enteral Solution as a prescription medication tailored for vulnerable infants. This significant move represents a pioneering step in neonatal care, making Japan the first country to recognize a 100% human milk-based fortifier as a prescription drug.

What is PreemieFort?

PreemieFort is specifically designed for very low birth weight infants, those with congenital gastrointestinal disorders, congenital heart diseases, and babies recovering from gastrointestinal surgeries. This fortifier, noted for its focus on human milk, aims to enhance the nutritional intake of the most fragile infants in Neonatal Intensive Care Units (NICUs). The approval is bolstered by the collaboration with Clinigen Group, which oversees the marketing and distribution of Prolacta’s products in Japan.

Clinical Evidence Supporting the Approval

The decision from the MHLW was supported by substantial clinical evidence collected from the JASMINE trial, a comprehensive randomized controlled study focused on evaluating the growth and safety of infants fed with exclusive human milk diets. This pivotal trial demonstrated that infants receiving human milk-based fortifiers like PreemieFort exhibited superior growth outcomes without a corresponding increase in morbidity or mortality rates.

The impressive success rates achieved in Japan, which boasts some of the highest preterm survival rates globally, highlight the efficacy of human milk-based nutrition. In particular, the country has one of the lowest incidences of necrotizing enterocolitis (NEC), a serious condition affecting premature infants, thus establishing a benchmark for neonatal health standards worldwide.

Scientific Endorsements of Human Milk-Based Fortifiers

Scott Elster, CEO of Prolacta Bioscience, remarked on the approval, stating, “Japan’s validation of PreemieFort as a prescription drug underscores the robust clinical evidence supporting our 100% human milk fortifiers.” He emphasized how this approval aligns with the rigorous quality and safety standards expected in Japan, often regarded as a leader in healthcare.

Prolacta's human milk-based fortifiers do not substitute traditional nutrition methods but serve alongside them as effective solutions to complex nutritional needs in NICUs. The extensive testing and screening protocols of donor milk involved in producing these fortifiers ensures high-quality standards, catering to the most delicate populations.

Transforming Neonatal Care Globally

The implications of this approval go beyond Japan, setting a powerful precedent for neonatal care facilities worldwide. With the inclusion of three different Prolacta products—PreemieFort Enteral Solution 6, Enteral Solution 8, and Enteral Solution CF—having prescription status, this establishes a new paradigm in how NICUs can provide nutritional support to their most vulnerable patients.

Leading neonatal specialists, like Dr. Kate Tauber, have warmly welcomed this development. She emphasizes that the nutrition provided to premature infants has lasting impacts on their health and developmental outcomes for life. “Human milk-based fortifiers should meet the same rigorous safety expectations as other medications,” she asserted, underscoring the importance of maintaining the highest standards in infant nutrition.

Prolacta’s Commitment to Quality and Safety

Prolacta maintains an unwavering commitment to the safety, quality, and efficacy of its products through a stringent set of guidelines surrounding the processing and manufacturing of donor human milk. Their use of vat pasteurization is pivotal in ensuring both the safety of the milk and the retention of its bioactive components, essential for promoting immune health and development in infants.

With comprehensive quality measures in place, Prolacta has positioned itself as a leading provider of human milk-based nutrition. Over 125,000 premature infants globally have benefitted from their products to date, reflecting a vast commitment to advancing infant health.

Conclusion

As Japan sets a global example with the approval of PreemieFort as a prescription medication, the spotlight turns toward effective neonatal nutritional strategies that promise better health outcomes for the most at-risk infants. This pioneering decision not only enhances the standards of care in Japan’s NICUs but serves as an inspiration for other countries aiming to improve neonatal healthcare.

For more information, visit Prolacta Bioscience’s website and explore how this innovation is redefining the landscape of neonatal care.