ACI SANT'ANTONIO, Italy, July 22, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company headquartered in Italy, is pleased to announce that the Committee for Orphan Medicinal Products (COMP) of the European Medicine Agency (EMA) has issued a positive opinion concerning Orphan Drug Designation (ODD) for polihexanide in the treatment of fungal keratitis.
Avanzanite Bioscience Reports AKANTIOR® Received Positive CHMP Opinion and Announces Corporate Expansion Into 26 European Countries
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has backed approval for Akantior (polihexanide), a potential first medicine to treat acanthamoeba keratitis.
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.
Enforcement Report - Week of February 1, 2023
CATANIA, Italy, Oct. 19, 2021 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced today that the pivotal Phase III study on polihexanide 0,08% monotherapy in adults and adolescents with Acanthamoeba keratitis (AK), met its primary endpoint of 'clinical resolution rate over a 12-month timeframe'. It also demonstrated an encouraging safety and tolerability profile. Based on these results, SIFI will request an accelerated assessment and plans to file a Marketing Authorisation Application (MAA) at the European Medicines Agency (EMA) for polihexanide 0,08% monotherapy under the Centralised Procedure for Orphan-Designated Medicinal Products in the first half of 2022.
Enforcement Report - Week of April 24, 2019