EMA’s human medicines committee (CHMP) has adopted a positive scientific opinion for Ivermectin/Albendazole for the treatment of infections caused by several types of worm parasites including lymphatic filariasis, a neglected tropical disease.
Ivermectin/Albendazole is indicated for use in adults, adolescents and children 5 years or older, for the treatment of soil-transmitted helminth infections (STH), caused by different types of intestinal parasitic worms, which are spread through soil contaminated by human faeces in areas with poor sanitation. Among the worms responsible for these diseases are hookworms (Ancylostoma duodenale, Necator americanus), roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura) and a roundworm called Strongyloides stercoralis.
This medicine is also indicated for the treatment of microfilaraemia (the presence of worm larvae in the blood) in patients with lymphatic filariasis (LF). LF is a neglected tropical disease commonly known as elephantiasis, which impairs the lymphatic system and can lead to the abnormal enlargement of body parts, causing pain, severe disability and social stigma. Ivermectin/Albendazole is indicated for the treatment of cases of lymphatic filariasis caused by Wuchereria bancrofti, a parasite which is responsible for 90% of cases worldwide.
Soil-transmitted helminth infections are among the most common infections worldwide and according to estimates by the World Health Organization (WHO) they affect 1.5 billion people, approximately a quarter of the world's population. For lymphatic filariasis, the WHO estimated in 2023 that 657 million people in 39 countries were living in areas at risk, with 25 million men affected by hydrocele (scrotal swelling) and 15 million people with lymphoedema (swelling in body tissues).
This medicine combines two active substances: ivermectin and albendazole. Ivermectin is an antiparasitic agent used to treat a variety of infections, both in people and animals. Albendazole is also a broad spectrum antiparasitic used to treat several intestinal parasite infections. Both ivermectin and albendazole are included in WHO’s list of essential medicines.
When co-administered, ivermectin and albendazole act in synergy. Ivermectin targets the parasite’s nervous and muscular systems, causing paralysis, while albendazole disrupts the parasite’s metabolism and energy production. This dual approach immobilises and kills the parasite and improves the treatment’s effectiveness.
The development of Ivermectin/Albendazole holds a high public health value as it will bring concrete advantages to the effectiveness of mass administration programmes in countries where these diseases are endemic. It will help reduce the risk of incorrect dosage, improve adherence, and reduce manufacturing and transport costs. Ultimately, this will allow more people to be treated.
The safety and efficacy of Ivermectin/Albendazole is mainly based on the results of a phase II/III randomised clinical trial (ALIVE) including 1223 patients, which compared a single dose of the fixed dose combination (FDC) with a single dose of 400 mg of albendazole alone, as well as a 3-day FDC regimen with a single dose of 400 mg albendazole given alone for treatment of certain worms (whipworm, hookworm and roundworm).
The study demonstrated the superiority for both the FDC single dose and the 3-day FDC regimen in all subgroups for patients infected with whipworm (except for co-infected patients treated with the FDC single dose). For hookworm infections the trial showed superiority for the 3-day FDC regimen compared to the albendazole-alone single-dose regimen. The efficacy of the treatment in filariasis is inferred based on the results of a study conducted in Mali and published in 2010.
The most common side effects with Ivermectin/Albendazole are headache, abdominal pain and elevated liver enzymes.
The applicant, Laboratorios Liconsa SA,submitted the application under the EU-M4all procedure for high-priority medicines for human use intended for markets outside the European Union (EU). EMA’s positive scientific opinion will streamline the WHO prequalification and facilitate national registration of ivermectin/albendazole for use in public health programs in countries where the diseases are endemic.
Medicines submitted under the EU-M4all programme are assessed by the CHMP in collaboration with the WHO and the target countries, combining EMA’s scientific review capabilities with the epidemiology and local disease expertise of WHO and experts and national regulators in the target countries. Experts from WHO, Mozambique, Kenya and Ethiopia participated in EMA’s assessment.
The CHMP scientific opinion under the EU-M4All procedure supports global regulatory capacity building and contributes to the protection and promotion of public health beyond the EU by assessing medicines for countries where regulatory capacity may be limited. National regulators can rely on the CHMP's scientific assessment to decide on the use of the medicine in their countries.
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