Written and Reviewed by Team Pharmacally
Collaboration with WHO and African Nations Marks Milestone in Fight against Neglected Tropical Diseases
Introduction
A fixed-dose combination (FDC) of Ivermectin and Albendazole has received a positive scientific opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), marking a major advancement in the fight against neglected tropical diseases (NTDs). This endorsement, which is a component of the EU-M4all (Medicines for All) project, attempts to improve patients with lymphatic filariasis’s access to therapies for microfilaraemia and soil-transmitted helminth infections. This FDC, created by Laboratorios Liconsa, S.A. in partnership with the World Health Organization (WHO) and specialists from Mozambique, Kenya, and Ethiopia, is expected to expedite treatment and promote worldwide eradication initiatives. The drug will be sold as an orodispersible tablets that contain 400 mg of Albendazole and either 9 mg or 18 mg of Ivermectin.
Background: The Burden of Lymphatic Filariasis
About 1.5 billion people, or roughly 25% of the world’s population, are afflicted by soil-transmitted helminth infections, which are caused by intestinal worms like hookworms (Ancylostoma duodenale, Necator americanus), roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and Strongyloides stercoralis. Another crippling parasitic disease that affects the lymphatic system and causes severe disability and social stigma is lymphatic filariasis, also known as elephantiasis. In 2023, the WHO estimated that 657 million people in 39 countries were living in areas at risk for lymphatic filariasis.
Over 120 million people worldwide suffer from lymphatic filariasis; a crippling illness spread by mosquitoes and brought on by the parasites Wuchereria bancrofti and Brugia. Chronic infection prolongs poverty cycles in endemic areas by causing lymphedema, elephantiasis, and severe disability. Targeting larval stages and preventing transmission, the current treatment consists of yearly mass drug administration (MDA) of Albendazole and Ivermectin as separate pills. However, adherence is hampered by complicated regimens and pill burden, highlighting the need for more straightforward treatments.
ALIVE Clinical Trial
In order to evaluate the safety and effectiveness of a fixed-dose combination (FDC) of Albendazole and Ivermectin for treating soil-transmitted helminth (STH) infections, specifically those caused by Trichuris trichiura, hookworm, and Strongyloides stercoralis, in paediatric and young adult populations, the ALIVE (Albendazole-Ivermectin Evaluation) trial was conducted. It is an adaptive phase II/III study, and was carried out in nations including Ethiopia, Kenya, and Mozambique where the medicine will be distributed. Comparing this combined medication to the usual single-dose regimen of Albendazole alone was the goal of the trial.
As a public health tool to lessen the burden of STH on over a billion people globally, the clinical trial results raised hopes for significant progress towards the safe and effective control of all STH in line with the 2030 elimination of morbidity goals.
WHO Road Map to NTD Elimination (2020-2030)
Through diagnostic and treatment progress for lymphatic filariasis (LF) in 1997, the disease joined a group of six infectious diseases identified as either eradicable or potentially eradicable. The World Health Assembly proceeded to adopt Resolution WHA 50. 29, advocating for the disease’s eradication as an international public health issue. The World Health Organization initiated the Global Programme to Eliminate Lymphatic Filariasis (GPELF) in 2000 as a direct response to this appeal.
The year 2020 saw GPELF establish following objectives for the upcoming NTD Road Map (2021–2030):
- A total of 58 endemic nations (80%) have achieved validation for eliminating lymphatic filariasis as a public health issue by maintaining infection rates below target levels for four years post-MDA cessation and delivering essential care packages to all known patient areas.
- A total of 72 endemic nations execute post-MDA or post-validation monitoring programs.
- The total number of people needing MDA becomes zero.
The FDC Innovation
When used together, Ivermectin and Albendazole provide a synergistic treatment for several infections. Albendazole interferes with the parasite’s metabolism and energy production, whereas Ivermectin paralyzes the parasite by attacking its neurological and muscular systems. Both parasite clearance and treatment efficacy are improved by this dual mechanism. This combination improves compliance and streamlines dosage, especially in large-scale MDAs. The FDC’s pill count reduction is in line with WHO recommendations that support integrated approaches to eradicate lymphatic filariasis by 2030.
EU-M4all: Bridging Regulatory Gaps
By offering scientific assessments and regulatory assistance, the EU-M4all program, led by the European Medicines Agency (EMA), expedites access to necessary medications in low- and middle-income countries (LMICs). In endemic nations, the CHMP’s favourable assessment serves as a prelude to WHO prequalification, facilitating quicker national approvals and guaranteeing timely launch. By filling in the gaps in NTD medication availability, this program demonstrates the EU’s commitment to global health fairness.
Collaborative Triumph: WHO and African Expertise
This FDC was developed using information from the WHO’s NTD Department and medical professionals in the endemic countries of Ethiopia, Kenya, and Mozambique. By taking into account elements like climate, infrastructure, and community customs, their involvement guaranteed that the regimen was appropriate for local situations. “This collaboration exemplifies how shared expertise can yield solutions tailored to the needs of affected populations,” stressed Dr. Matshidiso Moeti, WHO Regional Director for Africa.
Public Health Implications
The FDC’s approval holds transformative potential:
1. Enhanced Adherence: Simplified dosing could improve MDA participation, critical for interrupting disease transmission.
2. Cost Efficiency: Streamlined production and distribution may lower costs, optimizing limited health budgets.
3. Synergistic Benefits: The combination may also target co-endemic conditions like soil-transmitted helminths, amplifying public health impact.
Challenges and Next Steps
Even with the removal of regulatory obstacles, it is still difficult to provide fair access, especially in rural areas. It will be crucial to increase production, obtain financing, and fortify health systems. In order to promote acceptability, the EU-M4all program, WHO, and partner governments want to fund healthcare worker training and community involvement.
Conclusion
In the battle against lymphatic filariasis, the CHMP’s support of the Ivermectin/Albendazole FDC represents a significant advancement. This effort highlights the value of cooperation in combating NTDs by bringing together regulatory excellence, global health leadership, and local experience. The FDC is a shining example of creativity and a tribute to what can be accomplished when nations come together for health equity as they approach WHO’s 2030 targets.
References
- Ivermectin/Albendazole, Summary of opinion, Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency
- New combination of medicines to treat parasitic worm infections, European Medicines Agency, 31 January 2025
- Ivermectin/Albendazole – opinion on medicine for use outside EU, European Medicines Agency, 30 January 2025
- Europe Approval Facilitates Worm Treatment Where It Matters, Medscape, 31 January 2025
- Krolewiecki A, Enbiale W, Gandasegui J, et al,. An adaptive phase II/III safety and efficacy randomized controlled trial of single day or three-day fixed-dose Albendazole-Ivermectin co-formulation versus Albendazole for the treatment of Trichuris trichiura and other STH infections. ALIVE trial protocol. Gates Open Res. 2022 May 5;6:62. Doi: 10.12688/gatesopenres.13615.1. PMID: 36540062; PMCID: PMC9714317.
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- Hürlimann, Eveline et al., Efficacy and safety of co-administered Ivermectin and Albendazole in school-aged children and adults infected with Trichuris trichiura in Côte d’Ivoire, Laos, and Pemba Island, Tanzania: a double-blind, parallel-group, phase 3, randomised controlled trial, The Lancet Infectious Diseases, Volume 22, Issue 1, 123 – 135
- Mathew CG, Bettis AA, Chu BK, English M, et al, The Health and Economic Burdens of Lymphatic Filariasis Prior to Mass Drug Administration Programs. Clin Infect Dis. 2020 Jun 10; 70(12):2561-2567. Doi: 10.1093/cid/ciz671. PMID: 31343064; PMCID: PMC7286370.
- Lymphatic filariasis, World Health Organization, 21 Nov 2024 available from https://www.who.int/news-room/fact-sheets/detail/lymphatic-filariasis
- Lymphatic filariasis (Elephantiasis), World Health Organization, available from https://www.who.int/health-topics/lymphatic-filariasis#tab=tab_1
- Control of Neglected Tropical Diseases, World Health Organization available from https://www.who.int/teams/control-of-neglected-tropical-diseases/lymphatic-filariasis/global-programme-to-eliminate-lymphatic-filariasis
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