#Italy #AKANTIOR #SIFI #Acanthamoeba #Catania

SIFI Advances Regulatory Pathways for AKANTIOR®

SIFI, a prominent international company in the ophthalmic sector, recently reported significant progress on the regulatory front for AKANTIOR®, its treatment aimed at acanthamoeba keratitis (AK). This breakthrough comes as the company embarks on acquiring regulatory approvals in both the United Kingdom (UK) and the United States (US).

In the UK, SIFI has taken crucial steps by submitting a Marketing Authorization Application (MAA) and an Active Substance Master File (ASMF) to the Medicines and Healthcare products Regulatory Agency (MHRA). These submissions are pivotal for AKANTIOR®, which has already been recognized by the European Commission as an orphan medicinal product. Additionally, SIFI has applied for an Orphan Drug Designation (ODD) and a Promising Innovative Medicine Designation, both of which will be evaluated during the regulatory process. This move aligns with SIFI’s extensive commitment to enhancing global patient access to innovative therapies.

Meanwhile, in the United States, SIFI’s regulatory strategy remains robust. The company recently conducted a Type C meeting with the Food and Drug Administration (FDA) to solidify its approach ahead of a New Drug Application (NDA) submission slated for the latter half of 2025. The insights garnered from this critical meeting indicated that the data package, comprising both clinical and non-clinical information, is adequate for the NDA submission. Prospective approval for AKANTIOR® is anticipated by 2026, indicating a bright future for this innovative treatment as SIFI aims to address a growing medical need in the US.

Fabrizio Chines, the Chairman and CEO of SIFI, expressed optimism surrounding these developments: "Following the successful pivotal trial, approval and the commercial launch in the European Union, the regulatory submissions mark another vital milestone in our commitment to making AKANTIOR® the first and only approved treatment for AK, available globally."

Acanthamoeba keratitis (AK) is a rare but acute parasitic infection of the cornea caused by the Acanthamoeba species, with a troubling increase in incidence in recent years. Typically affecting young and middle-aged individuals who wear contact lenses, the condition necessitates urgent medical intervention to prevent severe consequences such as vision loss or the need for corneal transplants. Patients suffering from AK often endure excruciating pain and extreme sensitivity to light, significantly impairing their daily activities and quality of life.

SIFI’s AKANTIOR® is notable for being the world’s first and only approved treatment for this severe condition. This anti-amoebic drug, formulated with a concentration of 0.08% polihexanide, actively targets both the active trophozoites and the dormant cysts of the acanthamoeba protozoan, offering a promising solution for those afflicted by this nefarious infection.

The launch and subsequent success of AKANTIOR® in the European Union have established SIFI’s strong reputation in the ophthalmic market. As the population relying on contact lenses is significantly higher in the US than in Europe, SIFI aims to fill a critical gap in addressing the medical needs presented by this harmful infection.

About SIFI

Founded in 1935 and headquartered in Italy, SIFI has evolved into a leading name in ophthalmic care, integrating research, development, manufacturing, and commercialization across both the pharmaceutical and biomedical sectors. With a commitment to enhancing lives through innovation, SIFI operates in over 60 countries and is making significant strides to revolutionize eye care treatments worldwide. For more information about SIFI and its range of products, visit SIFI Group's website.