SIFI Advances Regulatory Pathway for AKANTIOR® in the UK and US for Acanthamoeba Keratitis
核心洞察
SIFI's submission of the Active Substance Master File and Marketing Authorization Application for AKANTIOR® in the UK paves the way for potential approval in Q2 2025.
A Type C meeting with the FDA confirms that existing pre-clinical and clinical data are adequate for a New Drug Application submission for AKANTIOR® in the US.
The anticipated approval of AKANTIOR® in the US, is expected in 2026, marking a significant step for treating Acanthamoeba Keratitis (搜索), especially among contact lens wearers.
SIFI, an international ophthalmic company, has achieved key regulatory milestones for AKANTIOR® in both the United Kingdom and the United States, marking progress in the treatment of Acanthamoeba Keratitis (搜索) (AK). The company's efforts aim to address this rare and severe parasitic corneal infection, particularly prevalent among contact lens wearers.
UK Regulatory Submission
SIFI has submitted a Marketing Authorization Application (MAA) for AKANTIOR® and an Active Substance Master File (ASMF) for its GMP-grade polihexanide to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. This action follows the European Commission’s authorization of AKANTIOR® as an orphan medicinal product and confirmation of eligibility for the International Recognition Procedure from the MHRA. The company has also applied for an Orphan Drug Designation (ODD) and a Promising Innovative Medicine Designation, which will be evaluated during the regulatory process.
US Regulatory Strategy
In the United States, SIFI held a Type C meeting with the Food and Drug Administration (FDA), outlining its strategy for a New Drug Application (NDA) submission in the second half of 2025. Feedback from the meeting supports SIFI's belief that its existing clinical and non-clinical data package is sufficient for NDA submission and potential approval of AKANTIOR® in the US, anticipated in 2026. The FDA has already granted ODD for the US patent in 2025 and New Chemical Entity status for polihexanide upon approval.
Clinical Significance and Market Impact
Fabrizio Chines, Chairman and CEO of SIFI, emphasized the importance of these regulatory advancements, stating, "Following the successful pivotal trial, approval and the commercial launch in the European Union, the regulatory submission in the UK and the pre-submission meeting in the USA mark further important milestones in our commitment to making AKANTIOR®, the first and only approved treatment for AK, available to patients globally." He also noted that the proportion of contact lens wearers in the USA is four times higher than in the European Union, suggesting a potentially greater impact for this innovative medicine in addressing the medical and social needs of patients suffering from this devastating disease.
About Acanthamoeba Keratitis
AK is an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba. The incidence of AK has been rapidly growing in recent years. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve.
About AKANTIOR®
AKANTIOR® (polihexanide 0.08%) is the first and only approved drug for the treatment of AK in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers.