CHMP positive recommendation for Akantior (polihexanide) for the treatment of acanthamoeba keratitis.- SIFI SpA
SIFI announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Akantior (polihexanide under the international non-proprietary name), for the treatment of acanthamoeba keratitis, a rare ophthalmic disease.
"We are very pleased to have received this positive opinion from the CHMP for AKANTIOR®. If approved, this innovative therapeutic solution will help patients suffering from acanthamoeba keratitis, a condition that is very debilitating in daily life and could lead to corneal transplant or enucleation of the eye, if untreated. We have been innovating in ophthalmology for almost 90 years and Akantior represents a significant milestone as well as a proof of our commitment to address unmet medical needs in our field. We are also very encouraged by the efficacy and safety of Akantior being replicated in several early access programs, which enrolled over 180 patients during the last 17 months in 12 countries in Europe and beyond." said Fabrizio Chines, Chairman and CEO of SIFI.
"Following 15 years of research, culminating in a pivotal Phase III clinical trial, polihexanide 0.08% was developed as the first licensed treatment for AK. Our studies have shown that when used as monotherapy, together with the treatment delivery protocol established for use in the trial, medical cure rates of over 86% can be achieved. I expect this to become the standard of care for this severe disease." stated Professor John Dart (Moorfields Eye Hospital and the University College of London, Institute of Ophthalmology), principal investigator of the Phase III trial.
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