Japan Approves Groundbreaking Infant Nutrition Product by Prolacta Bioscience

A Groundbreaking Development in Infant Nutrition

Prolacta Bioscience has marked a significant milestone in neonatal care with the recent approval of its PreemieFort® enteral solution by Japan’s Ministry of Health, Labour and Welfare (MHLW) as a prescription medication designed for vulnerable infants. This innovative product is entirely made from human milk and targets critical nutritional needs for premature babies and those facing serious health conditions. The approval signifies a major step forward in the realm of infant nutrition and sets a precedent for similar products in international markets.

Background of the Approval

The MHLW's decision to authorize PreemieFort as a prescription drug is a landmark achievement for Prolacta Bioscience, which has collaborated with Clinigen Group to manage the registration and distribution in Japan. PreemieFort is specifically intended for infants with very low birth weight, those suffering from congenital gastrointestinal diseases, congenital heart conditions, or infants recovering from gastrointestinal surgeries. The clinical evidence supporting this decision is anchored in a comprehensive clinical study conducted in Japan, known as the JASMINE study.

This study demonstrated significant growth benefits for infants provided with a diet exclusively comprising Prolacta’s human milk-based supplements, without increasing rates of morbidity or mortality. This showcases the potential life-saving impact of tailored nutrition for some of the most vulnerable patients in neonatal intensive care units (NICUs).

Significance of Human Milk-Based Nutrition

The approval highlights the critical role of human milk in infant nutrition, particularly for those born prematurely or with severe medical conditions. Japan is recognized globally for its advanced newborn care, showcasing the highest survival rates for premature infants along with low occurrences of necrotizing enterocolitis (NEC), a severe gastrointestinal disease.

Scott Elster, CEO of Prolacta Bioscience, emphasized the importance of the clinical validation process and the high standards of pharmaceutical quality that Prolacta adheres to. This approval is not just a regulatory achievement but a testament to the rigorous scientific evidence supporting the benefits of human milk-based nutrition.

Prolacta’s Commitment to Quality

Prolacta Bioscience is committed to maintaining the highest quality and safety standards in the industry. Their nutritional products have been utilized in treating over 125,000 vulnerable preterm infants worldwide, demonstrating a solid track record of efficacy and safety in challenging circumstances. The rigorous testing protocols for donor milk, including more than 20 safety tests and the use of vat pasteurization, ensure that the bioactive components of human milk are preserved, providing optimal support for the immune systems and development of premature infants.

Clinical studies consistently reveal the positive health outcomes associated with Prolacta’s fortified human milk products, indicating their critical role in enhancing survival and health in neonatal care settings.

Moving Forward

The approval of PreemieFort as a prescription medication paves the way for broader recognition and acceptance of human milk-based supplements in NICUs across the globe. Dr. Kate Tauber, a leading figure in pediatric nutrition, remarked on the life-altering potential that proper nutrition can offer to the smallest patients, asserting that all supplements should meet the same rigorous standards as traditional therapies.

The momentum created by Japan’s decision will likely inspire similar pathways in other countries, leading to improved health outcomes for countless infants facing precarious beginnings in life. As this field continues to evolve, Prolacta remains at the forefront, dedicated to enhancing the health of the most vulnerable populations through innovative nutritional solutions.