New sleeping sickness pill gets nod, paving the way for use in Africa

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NEW YORK (AP) — European drug regulators on Friday endorsed a new and simpler treatment for sleeping sickness, in what could be a giant boost to efforts to eliminate the disease.

A European Medicines Agency committee gave its nod to acoziborole, made by Sanofi. The decision is seen as a crucial step to making the medicine available in Congo, the country with the most sleeping sickness cases, and paving the way for its use in other African countries.

The product's proponents say three of the pills, taken together as a one-time dose, are an easier and far more accessible treatment than current regimens, which can require arduous trips to hospitals.

“This disease is on the brink of elimination" and the new drug could accelerate progress toward finishing the job, said Dr. Junior Matangila of the Drugs for Neglected Diseases initiative, an international organization focused on new treatments.

If sleeping sickness could be eliminated, it might be the first time spread of an infectious disease was erased without a vaccine, Sanofi officials noted.

Monica Mugnier, a sleeping sickness researcher at Johns Hopkins University, said the drug is a major treatment improvement but that it's yet not clear exactly how big a turning point its approval will be. There are still questions about where the disease-causing parasite is lurking, for example.

"This isn't solved yet,” she said.

Sleeping sickness is spread by tsetse flies found only in rural, sub-Saharan Africa. The flies bite people and infect them with a parasite.

Infections can start with vague, flu-like symptoms, and then worsen as the parasites multiple and fan out through the body — including into the nervous system. One result is the namesake symptom: a flipped sleep cycle in which people are awake at night but drowsy during the day. Coma and death can occur if it's not treated.

Researchers have been unable to develop a vaccine against the wormlike microscopic parasite because it has a unique ability to alter its protein coat, making it difficult to design an enduring immune system defense, Mugnier said.

The battle against the parasite has relied on efforts to kill off the flies and on medicines to save infected people. It's been difficult. Many of the infected are living in remote areas without access to hospitals.

“It's a disease of poverty,” said Matangila, who is based in Congo.

Sleeping sickness surged in the 1970s and 1990s amid political and economic instability in sub-Saharan Africa. Not helping was that the traditionally available medications were toxic and painful.

Treatments improved in the early 2000s and were a major reason for a dramatic decline in reported infections, which in 2009 dropped to below 10,000 for the first time in a half century. In 2024, there were fewer than 600 reported cases of the most common version of sleeping sickness, although it's not known how many people are infected and undiagnosed.

The World Health Organization has set a goal to stop the spread of that form of sleeping sickness by 2030.

Current treatments can take 10 days and require difficult trips to hospitals from remote villages. Many patients have had to undergo spinal taps, to help doctors understand the stage of infections — and which drugs to use.

Enter acoziborole. A small but pivotal study of about 200 patients in Congo and Guinea found that more than 95% of treated patients were considered cured 18 months later.

Sanofi officials used that study as a basis to push for approval of the drug for the most common form of human sleeping sickness. It can be used for people ages 12 and older, to treat both early and advanced-stage infections — taking away the need to do spinal taps.

Sanofi has pledged to donate doses to the World Health Organization, so the drug will be free to patients.

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