EC approval for SIFI’s Akantior to treat AK
Italian ophthalmics company SIFI SpA says that the European Commission has approved Akantior (polihexanide) for the treatment of acanthamoeba keratitis (AK) in adults and children aged 12 years and older, confirming the orphan drug status.
This makes Akantior the first and only therapy approved in Europe for people with AK, a very rare, serious, progressive, and sight-threatening corneal infection characterized by severe pain and photophobia. AK is caused by a free-living amoeba, acanthamoeba, and primarily affects contact lens wearers.
The authorization comes after the European Medicines Agency’s (EMA) human medicines committee (CHMP) recommendation in May this year.
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