Clinigen Announces World-First Pharmaceutical Approval for Prolacta Bioscience's PreemieFort® Enteral Solution, Human Milk-Based Product in Japan

Clinigen United Kingdom Japan England

Clinigen obtained approval for Prolacta's "PreemieFort® Enteral Solution", a human milk-based fortifier, as an approved pharmaceutical product in Japan indicated for the "Nutritional management of neonates and infants presenting with weight gain failure such as very low birth weight (VLBW) infants."The approval was supported by data from the pivotal Japan-based JASMINE Phase III clinical trial, a randomised, open-label, parallel-group comparison study in VLBW infants.This first-of-its kind approval set a new regulatory precedent, bridged innovation to market access gaps, and most importantly, advanced infant care and patient access in a rigorous regulatory environment.View original content:https://www.prnewswire.co.uk/news-releases/clinigen-announces-world-first-pharmaceutical-approval-for-prolacta-biosciences-preemiefort-enteral-solution-human-milk-based-product-in-japan-302686337.html