Ukraine Ministry of Health Accepts Entolimod Dossier for Formal Review Under Regulatory Equivalence Pathway
Ukraine's Ministry of Health has accepted Valion Bio's Entolimod regulatory dossier for formal review under the country's Regulatory Equivalence Pathway. This follows the Ministry's earlier request for the submission, marking the initiation of a scientific and regulatory evaluation of Entolimod, a medical countermeasure for Acute Radiation Syndrome (ARS).
The Ministry's acceptance commences a review process that could lead to a regulatory decision in as few as 45 to 60 days, dependent upon the Ministry's questions and operational circumstances. Ukraine operates a facilitated "recognition" registration pathway for biological products, which leverages regulatory work from foreign authorities, including the U.S. Food and Drug Administration (FDA). This pathway could enable quicker evaluation of Entolimod, which has previously received FDA Fast Track and Orphan Drug designations.
This review is notable as it represents the first formal regulatory evaluation of Entolimod by an allied nation, potentially expanding its availability beyond U.S. development efforts. Valion Bio's contract development and manufacturing organization (CDMO), Velocity Bioworks, has demonstrated the capacity to produce approximately 1.3 million doses of Entolimod, aligning with national stockpile and allied-government requirements.
Michael K. Handley, Chief Executive Officer of Valion Bio, stated that this milestone indicates the importance of addressing the unmet need for effective treatments for ARS. He emphasized that Entolimod’s ability to protect both the hematopoietic system and gastrointestinal tract could prove critical in severe radiation exposure scenarios, as governments increase their preparedness for radiological emergencies.
Entolimod is designed as a selective TLR5 agonist, activating the NF-κB signaling pathway to prevent programmed cell death in bone marrow and GI epithelial tissues. Its unique properties differentiate it from current therapies, which primarily focus on stimulating recovery of white blood cells after radiation exposure.