In a world-first regulatory breakthrough, Clinigen and Prolacta Bioscience have secured pharmaceutical approval in Japan for a human milk-based medicine for preterm infants.
PreemieFort Enteral Solution's approval marks the first time a nutritional product derived from human milk has been recognized as a prescription medicine anywhere in the world.
Previously regulated as an infant formula in the US and Europe, PreemieFort now meets Japan’s stringent pharmaceutical standards. The milestone was achieved through data from the pivotal JASMINE Phase III clinical trial, a randomized, open-label study in VLBW infants, and represents a landmark moment for neonatal care in one of the world’s most exacting regulatory environments.
“Japan's approval reflects a clear regulatory judgment that this category warrants pharmaceutical-level oversight,” said Varun Sethi, CEO of Clinigen.
“Our role was to work closely with regulators to define a pathway where none previously existed, enabling a human milk-based product such as PreemieFort Enteral Solution to be reviewed and approved to the standards applied to medicines. This ensures that patient access is determined by quality, safety, and efficacy, not geography. We took a complex, new science asset and updated its regulatory status in Japan, unlocking a major market for our partner while helping to address the needs of vulnerable infants.”
Scott Elster, CEO of Prolacta, added: “We are proud to have broken through this regulatory ceiling with our partners at Clinigen. Securing Japan's approval for the world's first human milk-based fortifier as an important medicine in Japan underscores the strength of our pharmaceutical-grade manufacturing, quality systems, and clinical evidence. Clinigen's regulatory expertise, combined with Prolacta's patented human milk-based products, helped make this landmark approval possible, and enables access to more babies in need worldwide.”
PreemieFort Enteral Solution is intended for VLBW infants and other neonates struggling with weight gain due to conditions such as congenital gastrointestinal or heart disorders, or recovery from gastrointestinal surgery. The approval highlights the critical role of human milk-based nutrition in supporting at-risk infants.
