The EMA's human medicines committee (CHMP) has issued a good scientific opinion on Ivermectin/Albendazole for the treatment of illnesses caused by a variety of worm parasites, including lymphatic filariasis, a neglected tropical disease.
Ivermectin/Albendazole is indicated for use in adults, adolescents, and children aged 5 and up to treat soil-transmitted helminth infections (STH) caused by various types of intestinal parasitic worms that spread through soil contaminated with human feces in poor sanitation areas. Hookworms (Ancylostoma duodenale, Necator americanus), roundworms (Ascaris lumbricoides), whipworms (Trichuris trichiura), and Strongyloides stercoralis are some of the worms that cause these disorders. This medication is also approved for the treatment of microfilaraemia (the presence of worm larvae in the blood) in patients with lymphatic filariasis. LF is a neglected tropical illness also known as elephantiasis that affects the lymphatic system and can cause abnormal expansion of body parts, resulting in discomfort, severe disability, and social shame. Ivermectin/Albendazole is recommended for the treatment of lymphatic filariasis caused by Wuchereria bancrofti, a parasite that accounts for 90% of cases globally.
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 medication comprises two active ingredients: ivermectin and albendazole. Ivermectin is an antiparasitic medication used to treat a wide range of infections in both humans and animals. Albendazole is a broad-spectrum antiparasitic used to treat a variety of intestinal parasite infections. Both ivermectin and albendazole are on WHO's list of essential medications. Ivermectin and albendazole work together to enhance its effectiveness. Ivermectin attacks the parasite's neurological and muscular systems, producing paralysis, whilst albendazole impairs the parasite's metabolism and energy production. This combined technique immobilises and kills the parasite, increasing the treatment's efficacy. The invention of Ivermectin/Albendazole has significant public health implications since it will improve the effectiveness of mass administration initiatives in countries where these diseases are prevalent. It will reduce the likelihood of wrong dosing, enhance adherence, and lower production and transportation costs. Ultimately, this will allow more patients to receive treatment.
The safety and efficacy of Ivermectin/Albendazole are based on a phase II/III clinical trial comparing single doses of the fixed dose combination (FDC) with albendazole alone and a 3-day FDC regimen for treating worms. The study showed superiority for whipworm infections and hookworm infections. The treatment's efficacy in filariasis is inferred from a 2010 Mali study.
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. 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.
Learn more: New combination of medicines to treat parasitic worm infections | European Medicines Agency (EMA)
