Sanofi's sleeping sickness drug wins FDA OK and a lucrative priority review voucher too
The FDA on Tuesday approved the first oral treatment for sleeping sickness (human African trypanosomiasis) from Sanofi and the Drugs for Neglected Diseases initiative, and provided the partners with a priority review voucher that they may sell for about $100 million.
Sleeping sickness is a parasitic disease that’s transmitted through being bitten by tsetse flies and affects people living in remote, sub-Saharan Africa, which puts about 65 million people at risk of infection. But Sanofi has been able to drastically reduce the number of sleeping sickness cases in sub-Saharan Africa by about 97% from 2001 and 2020, and fexinidazole, its oral-only drug, offers an advantage over other sleeping sickness treatments that require infusions or injections, and which are challenging to administer to patients in remote parts of Africa.
“Having a simple, all-oral treatment for sleeping sickness is a dream come true for frontline clinicians,” DNDi executive director Bernard Pécoul said in a statement. “We are proud of this latest milestone in our long-term partnership with Sanofi, developed in close collaboration with researchers in countries hard-hit by sleeping sickness.”
Patients take fexinidazole once a day for 10 days. It works to treat the first stage of the disease, as well as the second, which often leads to patients experiencing neuropsychiatric symptoms due to parasites crossing the blood-brain barrier.
In November 2018, the EMA endorsed fexinidazole as it was pushed through using a non-profit model. A group of seven European countries joined the $62.5 million development campaign, and received support from the Bill & Melinda Gates Foundation and Médecins Sans Frontières.
Sanofi said it will provide the drug to the WHO for free. And any funds earned from the PRV will be shared between Sanofi and the DNDi to further other programs to treat sleeping sickness and other neglected diseases, Sanofi said.
The tropical disease PRV program, established in 2007, incentivizes companies to develop new drugs for such neglected diseases as tuberculosis, malaria, leprosy and others. And if a company wins approval for a drug under the program, the FDA rewards that company with a voucher that can be sold or exchanged on the open market. Most recently, Rhythm Pharmaceuticals sold its PRV in January for $100 million.