Akantior

Opinion

EMA has issued an opinion on this medicine

polihexanide

Overview

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Akantior¹, intended for the treatment of Acanthamoeba keratitis, a severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia. Acanthamoeba keratitis is a rare disease primarily affecting contact lens wearers.

The applicant for this medicinal product is SIFI SPA.

Akantior will be available as 0.8 mg/ml eye drops solution. The active substance of Akantior is polihexanide, an anti-infective for ophthalmological use (ATC code: S01AX24) with a mechanism of action that involves both disruption of Acanthamoeba cell membranes and damage to Acanthamoeba’s chromosomes.

The benefit of Akantior is a higher clinical resolution rate (defined as no corneal inflammation requiring treatment, no or mild conjunctival inflammation, no limbitis, scleritis or anterior chamber inflammation, and no relapse within 30 days of discontinuing all topical therapy) compared to historical data in patients who were not given anti-amoebal treatment. The most common side effects with Akantior are eye pain and ocular hyperaemia.

The full indication is:

Akantior is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age.

Akantior should be prescribed by physicians experienced in the diagnosis and treatment of Acanthamoeba keratitis.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

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¹This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.

CHMP summary of positive opinion for Akantior

AdoptedReference Number: EMA/248910/2024

Product details

• Name of medicine:
  Akantior
• Active substance:
  Polihexanide
• International non-proprietary name (INN) or common name:
  polihexanide
• Therapeutic area (MeSH):
  Acanthamoeba Keratitis
• Anatomical therapeutic chemical (ATC) code:
  S01AX
• EMA product number:
  EMEA/H/C/005858
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation applicant:
  SIFI SPA
• Opinion adopted:
  30/05/2024
• Opinion status:
  Positive