sleeping sickness

Sanofi announced Monday that the U.S. FDA has approved its oral sleeping sickness treatment, fexinidazole, in patients age 6 and older and weighing at least 20 kilograms. According to the press release, the approval also nets a tropical disease Priority Review Voucher for Sanofi’s co-developer, the Drugs for Neglected Diseases Initiative. Sanofi and DNDI will share the PRV benefits.

The EMA approved the drug in 2018.

The U.S. FDA this week added brucellosis (undulant fever), opisthorchiasis (liver fluke infection) and paragonimiasis (lung fluke infection) to its list of tropical diseases for purposes of priority review voucher awards because of the lack of a “significant market in developed nations” for treatments. Meanwhile, the agency dropped coccidioidomycosis (Valley fever) and clonorchiasis (Chinese liver fluke infection) for the opposite reason.

In other NTD news, researchers from Britain’s…

Sanofi announced last week that the European Medicines Agency (EMA) has approved its oral sleeping sickness treatment fexinidazole, co-developed with the Drugs for Neglected Diseases initiative.

This is the 10th medicine that EMA has recommended using its Article 58 mechanism, which allows the regulatory authority to assess medicines intended for use outside the European Union.

The U.S. National Institutes of Health has awarded the University of Georgia a $2.6 million grant to develop new drugs for trypanosomiasis, also known as sleeping sickness.

A university press release said its researchers discovered a small molecule that arrests the proliferation of the Trypanosoma brucei parasite. This led to a drug design that cured the disease in mice, which the university believes it can translate into a human therapy.