Europe Approval Facilitates Worm Treatment Where It Matters

Europe’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ivermectin-albendazole to treat soil-transmitted helminth infections, including the neglected tropical disease lymphatic filariasis. The positive opinion is for use of the medication in markets outside of the EU.

Ivermectin-albendazole is indicated for use in people aged 5 years or older. It kills various kinds of intestinal parasitic worms that spread through soil contaminated by human feces, including hookworms, roundworms, and whipworms. Such infections are among the most common infections worldwide, affecting around 24% of the global population.

The treatment is also indicated for treating lymphatic filariasis caused by Wuchereria bancrofti, a parasite known to cause 90% of cases globally. The condition impairs the lymphatic system and can lead to abnormal enlargement of body parts, causing pain, severe disability, and social stigma. The World Health Organization (WHO) states that in 2018, 51 million people worldwide had the condition. 

Both ivermectin and albendazole are on the WHO’s list of essential medicines. They work synergistically when combined. Ivermectin leads to paralysis by targeting the parasite’s nervous and muscular systems, and albendazole targets its metabolism and energy production. 

Evidence for the use of ivermectin-albendazole for treating soil-transmitted helminth infections mainly comes from ALIVE, a phase 2/3 randomized clinical trial that included more than 1000 participants and compared a single dose of combined ivermectin and albendazole vs three consecutive daily doses of ivermectin and albendazole or a single dose of albendazole. 

Ultimately, the cure rate for whipworm for the 3-day combined drug group stood at 97.2% compared with 82.9% for the single dose combined drug group and 35.9% for the albendazole alone group. For hookworms, the 3-day combined drug group had a 95% cure rate, whereas the single-dose combined drug group had a 79.8% cure rate and the albendazole group had a rate of 65.1%. 

Gastrointestinal symptoms were the most common mild-to-moderate adverse events in both combined drug groups, but they resolved within 48 hours without intervention. No serious events occurred. 

Evidence for the treatment of lymphatic filariasis using ivermectin-albendazole comes from a study conducted in 2010, which found that increasing the dosage and the frequency of the drug combination enhances suppression of microfilariae. 

Ivermectin-albendazole will be available in fixed doses as orodispersible tablets containing either 9 mg ivermectin and 400 mg albendazole, or 18 mg ivermectin and 400 mg albendazole. The most common effects of the drug combination include headache, abdominal pain, and elevated liver enzymes.

Ivermectin-albendazole should be used according to official guidelines, which may include guidance from the WHO and public health authorities.

The combination medicine was approved under the EU-M4all procedure for high priority medicines meant for human use in markets outside of the EU. The EMA’s positive opinion streamlines the WHO’s prequalification procedures and facilitates national registration of the drug for use in public health programs in countries where the diseases are endemic.

Annie Lennon is a medical journalist. Her writing appears on Medscape, Medical News Today, and Psych Central, among other outlets.