MHRA approves Akantior to treat acanthamoeba keratitis

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) today revealed it has approved Akantior (polihexanide) to treat acanthamoeba keratitis (AK).

The approval was granted to Italian ophthalmic company SIFI SpA, which noted it is currently engaged with the National Institute of Clinical Excellence (NICE) and expects to file a full reimbursement dossier by end of June 2025.

"Granting Marketing Authorization for Akantior and its recognition with the Positive PIM designation marks important progress in our mission to provide Acanthamoeba keratitis patients in the UK with access to this innovative treatment," said Manuela Marrano, executive director, regulatory and market access, SIFI, adding: "This recognition by the MHRA underscores the potential of Akantior to address this high unmet medical need, confirming Akantior has significant benefits for patients with severely debilitating conditions. We also look forward to continuing our interaction with NICE to ensure the widest access in the country for Akantior.”