European Commission grants marketing authorization to Akantior for Acanthamoeba keratitis
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Key takeaways:
- The authorization is supported by positive data from a phase 3 pivotal trial.
- Avanzanite Bioscience has exclusive rights to market Akantior in 26 countries in Europe.
The European Commission granted marketing authorization to Akantior for the treatment of Acanthamoeba keratitis, according to a press release from Avanzanite Bioscience.
The decision was backed by positive results from the phase 3 pivotal Orphan Drug for Acanthamoeba Keratitis (ODAK) trial, which included 135 patients. Of these patients, 84.8% were cured of Acanthamoeba keratitis (AK) after treatment with Akantior (polyhexanide, Avanzanite Bioscience). In addition, 66.7% of patients achieved full vision restoration without the need for optical cornea transplants.
According to the release, the drug is the first and only authorized medicinal treatment for AK globally. It previously received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use and a positive recommendation from the EMA Committee for Orphan Medicinal Products.
Akantior is the second rare disease medicine commercialized by Avanzanite, which has secured exclusive rights to commercialize the treatment in 26 countries in Europe.
“This marketing authorization is the beginning of a new chapter for the treatment of Acanthamoeba keratitis and a monumental victory for AK patients in Europe,” Adam Plich, founder and CEO of Avanzanite Bioscience, said in the release. “At Avanzanite, we are committed to supporting broad access to our innovative therapies and look forward to collaborating with local health authorities in 26 European countries to secure sustainable access agreements so we can save the eyes of as many eligible patients as possible.”
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