Japan approves Prolacta’s human milk-based fortifier for underweight infants as a pharmaceutical
Key takeaways
- Prolacta’s PreemieFort is the first human milk-based fortifier approved as a prescription drug rather than a standard infant formula.
- The solution is specifically authorized for the nutritional management of very low birth weight infants and those with congenital conditions.
- The approval was secured through a partnership with Clinigen, using Phase III clinical trial data to meet rigorous pharmaceutical standards.
Prolacta Bioscience’s PreemieFort Enteral Solution has received the world’s first prescription drug approval for a nutritional fortifier made from human milk.
While regulated as an infant formula in the US and Europe, it is now considered a pharmaceutical product in Japan marketed specifically for the “nutritional management of neonates and infants presenting with weight gain failure, such as very low birth weight infants.”
Clinigen, a medical products platform in Japan, supplies the product to this tightly regulated market overseen by the country’s Ministry of Health, Labor, and Welfare.
“Japan’s approval reflects a clear regulatory judgment that this category warrants pharmaceutical-level oversight,” says Dr. Varun Sethi, CEO at 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.”
Clinically banked nutrition
According to Clinigen, there are currently no other existing approved drugs made from human milk. The company highlights Japan’s global significance in neonatal care with some of the highest preterm survival rates, noting the critical role of human milk-based nutrition for these at-risk babies.
PreemieFort Enteral Solution also helps babies recovering from gastrointestinal surgery and those diagnosed with congenital gastrointestinal disorders or congenital heart diseases.
The recent pharmaceutical approval is backed by data from Japan’s JASMINE Phase III randomized clinical trial, an open-label, parallel-group comparison study in very low birth weight infants.
Clinigen applied its regulatory expertise in a collaboration with Prolacta Bioscience to pioneer, define, and execute the regulatory architecture to meet the quality, safety, and efficacy required for this authorization.
Prolacta has appointed Clinigen as its exclusive licensee and Marketing Authorization Holder in Japan.
Market for human milk fortifiers
Fortifiers derived from human milk form part of nutritional strategies for specific patient populations. While the category remains specialized, Clinigen says its continual growth requires robust regulatory frameworks to support product safety, quality, and patient access.
“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,” says Scott Elster, CEO of Prolacta.
“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.”
In an interview this week, Nutrition Insight spoke with Nootropics Depot founder and CEO, Paul Eftang, about the latest advances in analytical instruments that are closing the quality analysis gap between botanical supplements production and pharmaceutical rigor. The company showcased its suite of advanced quality testing methods.
