NEW YORK (AP) — Europe’s drug regulator on Friday approved a new, simpler treatment for sleeping sickness that could give a major boost to efforts to eliminate the disease.
The European Medicines Agency’s committee has given its approval to Sanofi’s acoziboror. The decision is seen as a key step towards making the drug available in Congo, which has the highest number of sleeping sickness cases, and paves the way for its use in other African countries.
Supporters of the product say taking three of the pills together as a one-time dose would be easier and more accessible than current treatment options, which can require strenuous trips to the hospital.
Dr. Junior Matangela of the Drugs for Neglected Diseases Initiative, an international organization focused on new treatments, said “this disease is on the verge of elimination” and new drugs could accelerate progress in doing so.
Sanofi officials noted that if sleeping sickness can be eliminated, it may be the first time the spread of an infectious disease has been eliminated without a vaccine.
Monica Mugnier, a sleeping sickness researcher at Johns Hopkins University, said the drug is a major treatment improvement, but it’s unclear how big of a turning point its approval will be. For example, questions remain about where disease-causing parasites lurk.
“This matter has not been resolved,” she said.
Sleeping sickness considered a disease of poverty
Sleeping sickness is spread by the tsetse fly found only in rural areas of sub-Saharan Africa. Flies bite people and infect them with parasites.
The infection may start with vague, flu-like symptoms and then worsen as the parasite multiplies and spreads throughout the body, including into the nervous system. The result is the symptom of the same name: a flipped sleep cycle in which people are awake at night but drowsy during the day. If left untreated, coma and death may occur.
Researchers have been unable to develop a vaccine against the tiny, worm-like parasite because of its unique ability to change its protein coat, which makes it difficult to engineer long-lasting immune system defenses, Meunier said.
The fight against the parasite relies on efforts to eliminate the flies and drugs to save infected people. It’s difficult. Many infected people live in remote areas without access to hospitals.
“It’s a disease of poverty,” said Matangela, who lives in Congo.
Cases have dropped in recent years
Sleeping sickness surged in the 1970s and 1990s due to political and economic instability in sub-Saharan Africa. It doesn’t help that traditional medicines are toxic and painful.
Improved treatments in the early 2000s were the main reason for the sharp decline in reported infections, which fell below 10,000 in 2009 for the first time in half a century. In 2024, there were fewer than 600 reported cases of sleeping sickness, the most common form, but it is unclear how many people are infected and undiagnosed.
The World Health Organization has set a goal of stopping the spread of sleeping sickness by 2030.
Current treatment can take 10 days and requires an arduous trip from a remote village to the hospital. Many patients have to undergo spinal taps to help doctors understand the stage of infection and what medications to use.
Enter Akoziborro. A small but pivotal study of about 200 patients in Congo and Guinea found that more than 95% of those treated were considered cured after 18 months.
Sanofi officials used the research as a basis for pushing for approval of the drug to treat sleeping sickness, the most common form of sleeping sickness in humans. It can be used in people 12 years and older to treat early and late infections, eliminating the need for a spinal tap.
Sanofi has pledged to donate doses to the World Health Organization so the drug will be available to patients free of charge.
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