SIFI Provides Regulatory Updates for Akantior (Polihexanide 0.8 mg/ml) in Europe and the United States
SIFI announced the accomplishment of several targets concerning the regulatory procedure of polihexanide 0.8 mg/ml for the treatment of acanthamoeba keratitis.
The Name Review Group of the European Medicines Agency (EMA) has approved Akantior as the trade name for the drug candidate. “We selected Akantior as a brand name as it radiates the strength patients with acanthamoeba keratitis urgently need when fighting this sight-threatening parasitic eye infection,” Jelle Kleijn, SIFI’s Global Head of Akantior, said in a company news release.
Following 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, SIFI held meetings with the EMA designated Rapporteurs late in 2021 to discuss the timelines and process of its potential regulatory approval.
Based on the Rapporteurs’ positive feedback and the strength of the trial results, the company remains confident in its original guidance to submit the Marketing Authorisation Application (MAA) with the EMA in the second quarter of 2022. The company will seek regulatory approval under the ‘centralised authorisation procedure’ pathway given polihexanide’s designation as an orphan drug.
“The progress we’ve made in the regulatory approval process since the positive results of the pivotal phase 3 trial reflects our commitment to bringing Akantior to patients with acanthamoeba keratitis as soon as possible,” stated Manuela Marrano, SIFI’s Executive Director of Market Access and Regulatory Affairs.
With regard to the United States, SIFI submitted a request for a ‘Type B’ meeting with the FDA, which is expected to take place in April 2022.
“I’m very proud of the diligence and passionate dedication of our team, as evidenced by the recent and meaningful accomplishments in Europe and USA,” stated Fabrizio Chines, Chairman and CEO of SIFI. “Considering that no licensed medicine currently exists for this life-altering disease, we believe there is a significant unmet need to provide an effective cure to patients. We look forward to working side-by-side with the most important regulatory agencies globally for an efficient and timely approval of Akantior.”
SIFI is evaluating different options for the commercialization of Akantior globally, including potential out-licensing agreements for regions beyond its core markets.