- Filing of ASMF and MAA sets the stage for a potential approval in Q2 2025 in the UK
- Type C meeting feedback confirms pre-clinical and clinical data are adequate for an NDA submission and potential approval of AKANTIOR® in the US
, /PRNewswire/ — SIFI, a leading international ophthalmic company, announced the accomplishment of a key milestone in the pursuit of regulatory approvals in the United Kingdom (“UK”) and regulatory progress for filing in the United States of America (“USA“) for AKANTIOR® in the treatment of Acanthamoeba Keratitis (“AK”).
In the UK, SIFI submitted a Marketing Authorization Application (“MAA”) for AKANTIOR® and an Active Substance Master File (“ASMF”) for its proprietary GMP-grade polihexanide to the Medicines and Healthcare products Regulatory Agency (“MHRA”). This submission follows the European Commission’s authorization for AKANTIOR as an orphan medicinal product and the confirmation of eligibility for the International Recognition Procedure from the MHRA. SIFI also applied for an Orphan Drug Designation (“ODD”), which will be evaluated …