SIFI Announces EMA Validation of its Marketing Authorization Application for Akantior for the Treatment of Acanthamoeba Keratitis
SIFI announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for Akantior (polihexanide) for the treatment of acanthamoeba keratitis (AK).
Today's announcement follows the company’s announcement in October 2021 that the pivotal phase 3 trial of Akantior in adults and adolescents with acanthamoeba keratitis met its primary endpoint (ClinicalTrials.gov Identifier: NCT03274895). SIFI is evaluating different options for the commercialization of Akantior globally, including potential out-licensing agreements for regions beyond its core markets.
“Today’s announcement marks the culmination of an extensive research effort across the company to bring forward the first licensed therapy for acanthamoeba keratitis," Fabrizio Chines, Chairman and CEO of SIFI, said in a company news release. "I would like to take this opportunity to extend my gratitude to our dedicated leadership and their staffs for their fortitude, skill, and execution capabilities to ensure we achieved this historic milestone. Once again, SIFI has brought to bear the innovation that has become synonymous with our company’s brand, and, in the case of Akantior, is underscored by the product’s proprietary formulation, novel dosing regimen and uniqueness as a mono-therapy."
Professor John Dart, the pivotal phase 3 clinical trial principal investigator and Honorary Clinical Professor at the Institute of Ophthalmology, University College London, stated, “AK is one of the most severe and painful eye infections and also one for which there is no licensed therapy. Most patients require months of treatment and 25% lose useful vision. Our 15 year drug development project culminated in October 2021 with the completion of the phase 3 clinical trial which has demonstrated a high medical cure rate. Our findings show that Akantior will provide a majority of AK patients the prospect of recovering their vision and quality of life; I hope that this will soon become the standard of care for treatment of this disease.” concluded Professor Dart.
Manuela Marrano, SIFI’s Executive Director of Market Access and Regulatory Affairs, stated “Based on our current estimates, we remain confident in our ability to start the commercial launch Akantior across Europe, including the United Kingdom (UK), by 2H23, which will include recommendation from the Committee for Medicinal Products for Human Use (CHMP) and approvals by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK”. The EMA has already granted polihexanide Orphan Drug Designation in this disease.