Sanofi (SNY) said Friday the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for Acoziborole Winthrop to treat of both early and advanced-stage gambiense sleeping sickness in patients aged 12 years and older.

The recommendation for Acoziborole Winthrop as a three-tablet, single-dose oral treatment, granted under an accelerated assessment procedure intended for countries outside the European Union, is expected to facilitate approval in the Democratic Republic of Congo and lead to an update of the World Health Organization's treatment guidelines for sleeping sickness, Sanofi said.

The positive opinion for Acoziborole Winthrop, which was co-developed by the Drugs for Neglected Diseases initiative, was based on a phase 2/3 study showing up to 96% success rates at 18 months across both early and advanced stages of T.b. gambiense, the company said.

The company said that it will donate the medicine to the WHO through its philanthropic arm Foundation S.