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Avanzanite Bioscience reports on the Zulassung by the European Commission of Arzneimittels for seltene Leiden AKANTIOR®

Avanzanite Bioscience reports on the Zulassung by the European Commission of Arzneimittels for seltene Leiden AKANTIOR®

AMSTERDAM –

Avanzanite Bioscience BV, a specialized pharmaceutical company, which is engaged in developing new medicines for the market that it brings to the market, can do this by having the European Commission (EC) decide on the market for AKANTIOR® (Polihexanid) in the treatment of acanthamoebic keratitis (AK) in adults and children aged 12 years and above. The form adopted by the European Commission has made the positive notification of the positive attitude of the Australian Medicines Agency (CHMP) of the European Medicines Agency (EMA) who have conducted a positive review of the EMA approvals for the Medicines for Seltene Leiden (COMP). After more than 16 years of Research and Development (F&E), AKANTIOR is the first and only zugelassene Medicines for the treatment of AK-weltweit.

This press conference resulted in a multimedia inhalation. The complete Mitteilung can be found here: https://www.businesswire.com/news/home/20240826278963/de/

Adam Plich, Founder and CEO of Avanzanite Bioscience (Photo: Business Wire)

Adam Plich, Founder and CEO of Avanzanite Bioscience (Photo: Business Wire)

“There has been no research done, with AKANTIOR, as a monotherapy with most studies the treatment protocol eingesetzt, the medical treatment of 85% has been completed. When the AKANTIOR received the first medical treatment of the standard in the treatment, John Dart, leader of the phase III study of ODAK and professor at Moorfields Eye Hospital and University College London Institute of Ophthalmology. “It is a fact that the AKANTIOR has undergone the cure rate without surgical intervention and has caused the high morbidity risks – for all cases, the consequences of normal action, but if the blindness risks occur, it is not possible to do this, often together esetzten Combination therapies einhergehen, verringern wird.”

In March 2024, the phase III research study for acanthamoeba keratitis (ODAK) with 135 patients was published in the journal of clinical medicine, the absolute science and certainty of AKANTIOR. The study said that 84.8% of the patients, the AKANTIOR erhelelt, were cured. Therefore, 66.7% of the patients treated by AKANTIOR have a complete recovery from the disease, which means that the patient has done well with an optic horn transplant. Only 7.5% of the patients examined with AKANTIOR are a therapeutic optic horn transplant.

“If the Kämpferin de Acanthamoeba-Keratitis (AK) is probably, that AKANTIOR has had a beddeutenden and positive Einfluss on the AK-Patients,” commented Juliette Vila Sinclair Spence, who is for Patients with Seltenen Krankheiten einsetzt, Vorsitzende and Gründerin der AK Eye Foundation is one of the first global foundations to support the quality of money. Once AK diagnostics are complete, proceed to your medical or standard treatment protocols with AKAntiOR. I need to use another combination or a non-zugelassene augentropfen or a valid protocolverlassen. Diese Zulassung hat my Leidenschaft und my Engagement, das Bewusstsein für diese seltene Augenkrankheit zu schärfen, new entfacht.’

Acanthamoeba keratitis (AK) is a rare, severe and strong parasitic horn infection that develops over time Acanthamoebaa free amoeba, is suspected. A more urgent medical intervention is necessary, the disease to blindness and eye loss is induced. AK has made a great effort or more horn transplantation with comparatively small consequences of the transplantation. The reports of patients of unreliable pains and extreme light complaints and complaints can now only assume a normal lifestyle, but the symptoms disappear, so the patients may suffer from a trauma. AK concerns for all contacts and is for 50% of the blindness cases in the responsible population group. Without an anti-amoeba treatment 80.4% of patients must be operated, must themselves e.g. a therapeutic horn transplantation or an additional treatment – in a historical study of 56 patients.

“No one, with such a glaringly rare disease, should be left alone. This market operation is a new chapter for the treatment of Acanthamoeba keratitis (AK) and a monumental attack for AK patients in Europe,” says Adam Plich, founder and CEO of Avanzanit. “As our Research and Development Partners at SIFI, the medical care for the patients and the family, who have a study to tell, for his young commitment and his heartfelt thanks, which can make this day possible.”

We are very happy with the AKANTIOR im Rahmen eines Vorabgenehmigungsprogramms an more as 200 Patients in 12 Ländern abgegeben. “Wir bei Avanzanite setzen for one breiten Zugang to unseren innovative Therapien and freuen us auf the Zusammenarbeit with the locals Gesundheitsbehörden in 26 europäischen Ländern, een nachhaltige Zugangsvereinbarungen zu sichern, damit we so often berechtigten Patients who possible the Augen retten können “, schloss Duty.

Avanzanite has secured exclusive rights for the marketing of AKANTIOR in 26 countries of the European economic space and Switzerland through a partnership and supply agreement with SIFI, a leading international health company with headquarters in Italy. AKANTIOR is a healthy medicine for selected diseases, from the Avanzanite market. It is a fact that the external portfolio has its portfolio as one of the most important prices and non-interactive products of its portfolio, a global company for a select number of diseases will become.

ABOUT AKANTIOR ® : AKANTIOR (Polihexanid) is the first of the European Commission for the zugelassene Arzneimittel of AK. There is an anti-amöbic polymer, which can be used by the European Medicines Agency (“EMA”) and the Food and Drug Administration (“FDA”) as an Arzneimittel for seltene Krankheiten (ODD). die Zysten des Protozoen Acanthamoeba . There is a very high dosage of 0.8 mg/ml (0.08%) and a valid and standardized protocol as monotherapy-augentropfen in individual treatment. Polihexanid works for the treatment of pilz keratitis, for the treatment of the FDA as for the EMA and the ODD treatment.

ABOUT AVANZANITE BIOSCIENCE: If I enjoy the patient, all patients will use new drugs for a select number of drugs or drugs that make a profit, but that will not be the case. Our vision is that no one wants to earn their money, if there is a swaggering selection of Krankheit confrontation. If you see the human being, the care for the care and the development of new drugs for a part of the health care or the medical devices that you deserve, if you get a huge reinforcement of the patient’s life force, so that you can never save them again umsonst sein. If you get the chance to earn money or get into the spätfase before using the drugs for the selected diseases, it is possible to take advantage of your possibilities and sell your products, no one will suffer from it. The 2022 founded Avanzanite has its headquarters in Amsterdam, Netherlands, with a commercial infrastructure and technical facilities in the whole of Europe. For more information, visit www.avanzanite.com.

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Source: Business Wire