Business Wire

Avanzanite Bioscience Reports AKANTIOR ® Received Positive CHMP Opinion and Announces Corporate Expansion Into 26 European Countries


Avanzanite Bioscience B.V. (“Avanzanite” or the “Company”), a commercial-stage specialty pharmaceutical company, solely focused on medicines for rare diseases, announced today that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion recommending Marketing Authorisation of AKANTIOR® (polihexanide) for the treatment of acanthamoeba keratitis (“AK”) in adults and children from 12 years of age.

This press release features multimedia. View the full release here:

To view this piece of content from, please give your consent at the top of this page.

Adam Plich, Founder & CEO, Avanzanite Bioscience B.V. (Photo: Business Wire)

Today’s announcement follows Avanzanite’s licensing and supply agreement with SIFI, a leading Italian ophthalmic healthcare company, that was announced in January 2023, granting Avanzanite the exclusive rights to commercialize AKANTIOR in 26 countries in the European Economic Area and Switzerland.

Avanzanite’s Founder and CEO, Adam Plich, stated, “Avanzanite is a purpose-driven company whose sole mission is to ensure novel medicines reach patients suffering from rare diseases in every market across Europe and beyond. As such, the CHMP positive opinion takes us one step further in our unwavering pursuit of this important goal. No one facing such a monstrous disease should be left behind.” Mr. Plich added, “Through this strategic partnership, Avanzanite is unlocking access to a potential new treatment for those affected by AK in 26 European countries previously unavailable to SIFI.”

This CHMP opinion represents the culmination of more than 15 years of research by SIFI based on a comprehensive data package demonstrating AKANTIOR’s quality, safety, and efficacy. In March 2024, results of the Orphan Drug for Acanthamoeba Keratitis (ODAK) pivotal 135-patient Phase III study were reported and published in Ophthalmology. The trial showed that 86,7% of patients receiving AKANTIOR were cured with a median time to cure of 4,1 months. Furthermore, 66,7% of patients treated with AKANTIOR achieved full vision restoration and only 7,5% required a cornea transplant.

Following the CHMP’s recommendation to approve AKANTIOR for the treatment of AK, the European Commission (EC) will make its final Marketing Authorisation approval decision within approximately 2 months (currently expected in early August 2024). Meanwhile, AKANTIOR remains available through a pre-authorisation distribution program which, to date, has facilitated treatment access to more than 180 patients across 12 European countries.

Following the successful commercialization of Sibnayal®,AKANTIOR will be the second rare disease medicine commercialized by Avanzanite, expanding the company’s footprint across 26 European countries. In February 2023, Avanzanite announced its exclusive distribution agreement with Paris-based specialty pharmaceutical company Advicenne for Sibnayal, approved in the European Union for the treatment of children and adults with distal renal tubular acidosis (dRTA), a rare genetic or acquired kidney disease. Avanzanite’s dedicated team supplies Sibnayal across 8 countries.

ABOUT AVANZANITE BIOSCIENCE: Founded in 2022, Avanzanite is a privately-funded, commercial-stage, specialty pharmaceutical company solely focused on medicines for rare diseases. At Avanzanite we believe all patients should benefit from novel orphan or niche medicines regardless of where they live. Our vision is that no one is left behind when facing a debilitating rare disease. We also believe the people who have dedicated their careers to the research & development of novel orphan or niche medicines deserve to witness their tremendous efforts impacting patients’ lives – the work of these heroes should not lie in vain. We make this happen by acquiring, licensing, or distributing approved or late-stage medicines for rare diseases and commercializing them even where nobody else will. Headquartered in Amsterdam in the Netherlands, Avanzanite has commercial infrastructure and technical operations across Europe. Please visit for additional information.

ABOUT ACANTHAMOEBA KERATITIS (AK): AK is a rare, severe, and progressive parasitic corneal infection caused by Acanthamoeba, a free-living amoeba. Urgent medical intervention is required as the disease often leads to blindness and eye loss. AK often requires single or multiple corneal transplant procedures with comparably low graft survival rates. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve, leaving patients with trauma for life. While still very rare, the incidence of AK has grown rapidly in recent years. AK primarily affects contact lens wearers, accounting for 50% of blindness among them.

ABOUT AKANTIOR®: AKANTIOR (polihexanide) is an anti-amoebic polymer that has been granted Orphan Drug Designation (ODD) by both the European Medicines Agency ("EMA") and Food and Drug Administration ("FDA") for AK. It acts on both the trophozoites and cysts of the protozoan Acanthamoeba. It is formulated at a unique high 0.8 mg/ml dose strength which makes it possible to administer through a validated and standardized, day-only protocol as monotherapy eye drops in single-dose containers. Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA ODD.

To view this piece of content from, please give your consent at the top of this page.

Contact information

Adam Plich, Founder & CEO
Avanzanite Bioscience B.V.
+31 20 301 21 13

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

PMC Biogenix Announces Expansion and Restructure21.6.2024 23:00:00 CEST | Press release

PMC Biogenix, the leading sustainable producer of specialty fatty amides and high-value biobased products, announces the construction and expansion of its new Armoslip® facility in Gyeongju, South Korea allowing for a production capacity increase of 50%. Construction will begin late 2024 with new supply available by mid-2026. “We are excited to announce plans to build a new facility in Gyeongju. This investment will allow us to significantly increase production capacity to meet growing customer demand for our Armoslip products,” said Debtosh Chakrabarti, President, PMC Group N.A., Inc. Adding, “This project solidifies our commitment as the industry leader, delivering products and solutions to our customers, as well as to the local Gyeongju community. We appreciate the continued support of the Gyeongju, South Korea local government, community, and our customers.” As part of PMC’s ongoing commitment of ensuring long-term sustainability and success of the Biogenix business world-wide, a c

Esri Technology Used By ALS Therapy Development Institute to Map Clinical Trials21.6.2024 22:58:00 CEST | Press release

The ALS Therapy Development Institute (ALS TDI), a nonprofit biotech dedicated to ending amyotrophic lateral sclerosis (ALS), has used mapping technology from Esri, the global leader in location intelligence, to develop the ALS Trial Navigator. The new tool is designed to simplify and streamline the process by which people with ALS and their caretakers learn about current ALS studies. With the ALS Trial Navigator users can now explore an interactive map to find locations where applicable clinical trials are taking place. They can also receive a customized map based on their preferences and status of their ALS. "ALS Trial Navigator helps people living with ALS, those that might face it in the future, and researchers looking to enroll trials by educating the community and providing information about current studies all around the world," said Dr. Nadia Sethi, ALS TDI's director of community engagement, who oversaw the Navigator's design and creation. Once a person is diagnosed with ALS,

Lifezone Metals Announces Voting Results from its 2024 Annual General Meeting21.6.2024 22:30:00 CEST | Press release

Lifezone Metals Limited (NYSE: LZM) announces the results of voting by shareholders at its 2024 Annual General Meeting (the “AGM”) held today in the Isle of Man. The ordinary resolutions below were passed by shareholders, with voting results as follows: Ordinary Resolutions For % For Against % Against Abstain % Abstain To receive the Company’s accounts for the financial year ended December 31, 2023 60,456,134 100.00% 0 0.00% 264 0.00% To re-elect John Dowd as a Class I Director of the Company 60,375,930 99.87% 79,177 0.13% 1,291 0.00% To re-elect Govind Friedland as a Class I Director of the Company 59,713,208 98.77% 79,319 0.13% 663,871 1.10% To re-elect Ambassador Mwanaidi Maajar as a Class I Director of the Company 60,314,469 99.77% 81,886 0.14% 60,043 0.10% A total of 60,456,398 or 75.57% of Lifezone Metals Ordinary Shares outstanding were represented at the AGM. If you would like to sign up for Lifezone Metals news alerts, please register here. About Lifezone Metals At Lifezone Me

Takeda Receives Approval from European Commission for FRUZAQLA in Previously Treated Metastatic Colorectal Cancer21.6.2024 22:00:00 CEST | Press release

Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved FRUZAQLA (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2024, and approval by the U.S. Food and Drug Administration (FDA) for adults with mCRC who have been previously treated with oxaliplatin- and irinotecan-based regimens on November 8, 2023.1,2 “People living with metastatic colorectal cancer face numerous difficulties, stemming both from their illness and the adverse effects of therapies. Given the complex nature of the d

Vertex Announces Positive Results From Ongoing Phase 1/2 Study of VX-880 for the Treatment of Type 1 Diabetes Presented at the American Diabetes Association 84th Scientific Sessions21.6.2024 21:45:00 CEST | Press release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today presented new data from its Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated islet cell therapy, in people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemic events (SHEs). These updated data on 12 patients who received the full dose as a single infusion in Parts B and C of the trial are consistent with previously reported positive results in the VX-880 trial and reinforce the transformative potential of this therapy. At baseline, all patients in the study had undetectable fasting C-peptide (a marker of endogenous insulin secretion), a history of recurrent SHEs in the year prior to screening, and required an average of 39.3 (min, max; 19.8, 52.0) units of insulin per day. Following a single infusion of VX-880 at the full dose, all 12 patients demonstrated islet cell engraftment and glucose-responsive insulin production by Day 90. At the latest visi

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
HiddenA line styled icon from Orion Icon Library.Eye