SIFI has received the European Commission (EC) approval for Akantior (polihexanide) to treat acanthamoeba keratitis (AK), a rare infectious disease that can cause permanent blindness.
Akantior is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba, indicated to treat AK in adults and children aged 12 years and above.
The drug is formulated at a 0.8mg/ml (0.08%) concentration, which facilitates its administration as monotherapy eye drops in single-dose containers.
The EC approval follows a positive recommendation by EMA’s Committee for Medicinal Products for Human Use (CHMP), and Committee for Orphan Medicinal Products (COMP).
Akantior is the first and only therapy approved to treat AK in Europe, said the Italian drugmaker.
SIFI chairman and CEO Fabrizio Chines said: “Today’s approval represents an important step towards delivering a new global standard of care for patients with AK and builds on 15 years of research and development.
“For the first time in Europe AK patients have an approved therapy, marking a new era in the treatment of this disease, which may lead to blindness.
“Akantior is the first and only approved medicine for AK, and our team is committed to developing polihexanide in other corneal infectious diseases, such as fungal keratitis, where we obtained orphan drug designation from the EMA and the FDA.”
The EC marketing authorisation for Akantior was based on efficacy established in the Phase 3 ODAK clinical trial and comparison to historical control data.
In the Phase 3 study, 85% of patients receiving Akantior were cured with only 7% requiring a therapeutic cornea transplant and none needing an optical cornea transplant.
SIFI plans to begin commercialising Akantior in Europe during the last quarter of this year, based on local regulatory, healthcare technology assessment and reimbursement timelines.
The company will start with Germany and plans to expand the product to additional markets, including France, Italy, Romania, Spain, UK, and Turkey.
Furthermore, SIFI’s partner Avanzanite is collaborating with local health authorities to ensure access to Akantior across 26 European countries.
Phase 3 ODAK trial principal investigator John Dart said: “Akantior, when used as monotherapy with the trial’s treatment protocol, achieves medical cure rates of over 86% and is set to become the standard of care for this severe and debilitating disease.
“After 15 years of research and effort development by SIFI, culminating in the pivotal Phase III clinical trial, polihexanide 0.08% has now been approved by the European Medicines Agency and European Commission as the first licensed treatment for acanthamoeba keratitis.
“This breakthrough offers significant improvement over current treatment options and has the potential to prevent blindness and save eyes.”
