CHMP approves backing for first acanthamoeba keratitis treatment
临床3期引进/卖出孤儿药上市批准临床结果
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来源: Pharmaceutical Technology
Akantior’s commercialisation rights were acquired by Netherlands-based Avanzanite in January this year. Image credit: Shutterstock / Kateryna Kon.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has backed approval for Akantior (polihexanide), a potential first medicine to treat acanthamoeba keratitis.
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The CHMP will now send their recommendation of marketing authorisation – for patients aged 12 years and older with the infection – to the European Commission, with a decision expected in August 2024, according to a 3 June press release.
Developed by Italian ophthalmic healthcare company SIFI, Akantior’s commercialisation rights were acquired by Netherlands-based Avanzanite in January this year. The licensing and supply agreement includes 26 countries in the European Economic Area and Switzerland.
Acanthamoeba keratitis is an eye infection caused by an Acanthamoeba amoeba. The microorganism infects the cornea, leading to possible vision loss and blindness. The infection, which usually affects contact lens wearers, is treated off-label via various combinations of antiseptic and antifungal agents and, according to Avanzanite, by conducting corneal transplants.
Akantior is an anti-amoebic polymer that works on both forms of Acanthamoeba in the eye – the mobile trophozoites and the infective cysts. The drug is administered as monotherapy eye drops at 0.8mg/ml dose. Akantior’s active substance is polyhexanide.
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The positive CHMP opinion was based on more than 15 years of data, Avanzanite said. This includes a Phase III trial involving 135 patients with the infection. Results from the trial (NCT03274895) showed that 86.7% of participants receiving the drug were cured with a median time to cure of 4.1 months. Only 7.5% of patients required a cornea transplant, with 66.7% regaining full vision after treatment with Akantior.
Avanzanite’s CEO Adam Plich said the positive CHMP opinion takes the company “one step closer” to delivering the medicine to patients with the rare disease.
Akantior has been awarded orphan drug status by both the EMA and the US Food and Drug Administration (FDA) – meaning the company has enjoyed a suite of pre-market benefits and could be eligible for market exclusivity in the regions if approved.
In February 2023, Avanzanite announced an exclusive distribution agreement with French pharma company Advicenne for distal renal tubular acidosis (dRTA) treatment Sibnayal (potassium hydrogen carbonate / potassium citrate).
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