Sanofi gets positive EMA opinion for sleeping sickness treatment

Sanofi gets positive EMA opinion for sleeping sickness treatment

Dec 15 (Reuters) – French healthcare company Sanofi (SASY.PA) on Friday said the European Medicines Agency (EMA) had issued a positive opinion of its treatment for sleeping sickness, also called rhodesiense.

Sanofi’s Fexinidazole Winthrop is the first oral treatment for an acute form of sleeping sickness, a lethal parasitic disease transmitted by the bite of infected tsetse flies and found in 36 African countries, the company said.

The positive opinion is for the treatment of adults and children 6 and older who weigh at least 20 kg (44 lbs), in both the first and second stages of the sickness.

It follows clinical trials in Malawi and Uganda led by the non-profit medical research organization Drugs for Neglected Diseases initiative (DNDi), Sanofi said.

“Until now, due to the lack of innovation for this strain of sleeping sickness, old and toxic treatment options have to be administered in a hospital under strict surveillance. Having a simple and safer oral pill to treat this frightening disease will allow doctors to rapidly save lives,” said Dr Westain Nyirenda, principal investigator and physician at Rumphi Hospital in Malawi.