( MENAFN - PR Newswire) ACI SANT'ANTONIO, Italy, May 31, 2024 /PRNewswire/ -- 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 .
The CHMP recommendation will now be reviewed by the European Commission (EC), which may decide on the marketing authorisation (MA) for AKANTIOR® in August 2024. The decision will then be applicable to all member states of the European Union as well as to Iceland, Liechtenstein and Norway. The CHMP positive opinion .
