EMA publishes positive opinion on a fixed-dose combination of albendazole and ivermectin to treat parasitic worm infections
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive scientific opinion for the fixed-dose combination (FDC) of albendazole and ivermectin for the treatment of infections caused by soil-transmitted helminths (STH) and lymphatic filariasis (LF), in adults, adolescents and children aged 5 years or older.
The favourable assessment by EMA, based on the results of the ALIVE trial led by the STOP Consortium, represents a significant milestone for this pharmacological tool, advancing its potential for widespread adoption in endemic countries.
The FDC combines two antiparasitic medicines albendazole and ivermectin, which together target the four soil-transmitted helminths infections considered by WHO in their roadmap for neglected tropical diseases 2021-2030. Additionally, this combination serves as a key component of an effective treatment regimen for LF.
This innovative product, developed as a single tablet with a fixed-dose combination of the two medicines, is orodispersible and mango-flavoured, making it child-friendly and easy to administer and thus suitable for use in large-scale control programmes, including school-aged children.
To accelerate the implementation of this new treatment, Global Health EDCTP3 is supporting the STOP2030 project, which is assessing the safety and effectiveness of the fixed-dose combination in mass drug administration campaigns in Kenya and Ghana. The resulting information will be consolidated to build a multidisciplinary package for policy making and WHO guidance.
The application for EMA’s scientific opinion was submitted by Laboratorios Liconsa, the Spanish pharmaceutical company that produces the FDC part of the Insud Pharma Group, on behalf of the STOP project partners.
This consortium, funded by the second European & Developing Countries Clinical Trials Partnership programme (EDCTP2), conducted a pivotal adaptive phase 2-3 randomised clinical trial (ALIVE) in Ethiopia, Kenya and Mozambique that proved the safety and superior efficacy against Trichuris trichiura and broader coverage against multiple soil-transmitted helminth species, including Strongyloides stercoralis, of the FDC compared to albendazole monotherapy, the current standard for STH control.
The evaluation was under EMA’s EU-M4All procedure, aimed at high-priority medicines for countries outside the European Union.
EMA’s favourable assessment highlights a journey of innovations that started in 2010 in Argentina, under the auspices of Mundo Sano Foundation, but spans over 15 years of research involving 18 public and private institutions from Africa, Latin America and Europe.
The initiative gained traction in 2017 when Mundo Sano Foundation and EDCTP created a partnership to leverage research funding for neglected infectious diseases (NIDs), which subsequently provided the resources for the STOP 1 and 2 projects.
“We at Mundo Sano are thrilled to receive this positive scientific opinion from EMA. It reinforces our belief that collaboration is the best strategy for tackling the complexities of global health. Effective collaboration between the private and public sectors and among other disciplines is vital for achieving and sustaining programs. It’s also important to recognize the value of perseverance. The achievement we celebrate today began nearly 15 years ago with an initial pilot project in Salta, Argentina. Since then, we have scaled up and added partners, which made this amazing accomplishment possible. At this moment, we want to express our gratitude to everyone involved. This includes our partners, the researchers from various consortiums, Liconsa Laboratory that produced this innovative tablet, and EDCTP for supporting projects like this one. Each of them played a vital role in this success.”
Dr Silvia Gold, President of Mundo Sano foundation
“I am delighted that the work of the STOP Consortium, supported by the EDCTP programmes since 2017, and the strong partnerships forged with Mundo Sano and Liconsa, has resulted in this positive scientific opinion from EMA. Research on both neglected infectious diseases and in underserved populations has been among the key priorities for EDCTP. Successful development and access to a suitable paediatric treatment for parasitic worm infections – through this global public-private partnership – will be a tangible contribution towards the Sustainable Development Goals by ensuring that school-aged children are not left behind. At Global Health EDCTP3, we felt it important to support the implementation of this new treatment and I look forward to seeing more results generated as part of the STOP2030 project, strengthening the data package in real-life settings.”
Dr Michael Makanga, Executive Director, Global Health EDCTP3
“We are very proud to be part of the STOP Consortium and to see the progress of the STOP2030 results. This joint effort speaks volumes about our approach to work and project management at Insud Pharma and through our Liconsa laboratories in Spain. From the beginning, we have advocated for public-private collaboration as the best way to preserve and promote our group's commitment to supporting initiatives that ensure access to healthcare and have a real impact. Science is also about providing access, which is why we are very proud of this collaboration between Liconsa, EDCTP, and, of course, Mundo Sano foundation.”
Lucas Sigman, CEO at Insud Pharma
About Mundo Sano
Mundo Sano is a family foundation whose mission is to improve access to healthcare for people affected by neglected diseases. It was founded in 1993 by Dr. Roberto Gold and taken on by his children as a family legacy with a clear mission: to give back to society.
Since its inception, its commitment has been to achieve greater health equity, with a strong vocation for contributing to Public Health. Through translational research and public-private cooperation, the Foundation generates scientific evidence to contribute to the design of health policies, articulating and influencing the global health agenda.
With offices in Buenos Aires and Madrid, Mundo Sano Foundation also has four branches in Argentina, strategically located in areas heavily affected by neglected diseases. Its presence in Spain facilitates a global approach to projects, linking with Africa, and fostering Ibero-American regional cooperation in its work.
The Foundation collaborates with local, regional, and global partners to develop programs, strategies, and medications that efficiently overcome barriers hindering access to healthcare for vulnerable populations.
About EDCTP (Association)
The mission of the European & Developing Countries Clinical Trials Partnership (EDCTP) is to reduce the social and economic burden of poverty-related diseases in developing countries, in particular sub-Saharan Africa, by accelerating the clinical development of effective, safe, accessible, suitable, and affordable medical interventions for HIV/AIDS, tuberculosis, malaria, neglected infectious diseases, lower respiratory tract infections, diarrhoeal diseases and infectious diseases of epidemic potential, including Ebola and COVID-19. EDCTP is supported by the European Union under Horizon 2020, its Framework Programme for Research and Innovation.
The ALIVE trial and the STOP projects were supported by the EDCTP2 programme (grant numbers RIA2017NCT-1845 and PSIA2020-3072), with co-funding from the Mundo Sano Foundation, the UK Medical Research Council, the UK Foreign & Commonwealth Office, and the European Union.
The STOP consortium is led by ISGlobal, Spain in partnership with Leiden University Medical Center (LUMC, The Netherlands), Universidad de León (ULE, Spain), Fundação Manhiça – Centro de Investigação em Saúde de Manhiça (CISM, Mozambique), Bahir Dar University (BDU, Ethiopia), Liconsa (Chemo, Spain), Kenya Medical Research Institute (KEMRI, Kenya) and the London School of Hygiene and Tropical Medicine (LSHTM, UK).
About Liconsa
Laboratorios Liconsa, located in Spain, is part of the Insud Pharma group and is one of the most advanced FDF plants and R&D centers in the world.
Insud Pharma is a pharmaceutical group with over 45 years of history, a presence in around 50 countries, 9,000 employees worldwide, and 20 manufacturing plants. Insud Pharma operates along the entire value chain of the pharmaceutical industry, offering specialized knowledge in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), and branded pharmaceutical products for human and animal care, as well as biopharmaceuticals. Insud Pharma aims to improve health globally by providing accessible, effective, safe, and quality pharmacological treatments through its various business units, with continuous investment in R&D and the latest technology. Insud Pharma has a presence at all levels of the chemical-pharmaceutical industry thanks to its synergistic brands Chemo (Industrial), Exeltis (Women’s Health, CNS…), mAbxience, and Algenex (biotech).
About Global Health EDCTP3
Established in 2021, Global Health EDCTP3 is a partnership between the European Commission, representing the European Union, and the EDCTP Association, representing the governments of 15 European and 30 sub-Saharan African countries.
Global Health EDCTP3’s mission is to reduce overall mortality and morbidity in sub-Saharan Africa by supporting global collaborative research, capacity strengthening, and international initiatives to accelerate the development, evaluation, and implementation of interventions to prevent, identify, treat, and track infectious diseases and emerging/re-emerging infections in the region.