French Drugmaker Sanofi Secures European Medicines Agency's Positive Opinion For Sleeping Sickness Treatment

Sanofi SA SNY, DNDi, and the HAT-r-ACC consortium announce that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive scientific opinion of Fexinidazole Winthrop as a first oral treatment of an acute form of sleeping sickness (rhodesiense). 

This positive opinion is for the treatment in adults and children six years of age or older and weighing at least 20 kg of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) Trypanosoma brucei (T.b.) rhodesiense sleeping sickness, an acute and lethal form of this parasitic disease found in Eastern and Southern Africa.

Also Read: French Pharma Giant Sanofi Drops Rare Disease Drug Pact As Federal Trade Commission Puts Antitrust Obstacle.

This CHMP opinion follows an application by Sanofi under Article 58 and clinical trials in Malawi and Uganda led by the non-profit medical research organization Drugs for Neglected Diseases Initiative (DNDi). 

Sleeping sickness, or human African trypanosomiasis (HAT), is usually fatal without treatment. The bite of infected tsetse transmits both forms of sleeping sickness flies, found in 36 African countries. It causes neuropsychiatric symptoms, including aggressiveness, psychosis, a debilitating disruption of sleep patterns that have given this neglected disease its name, and ultimately, death.

The CHMP opinion today paves the way for the update of WHO guidelines on treatment for sleeping sickness and distribution by WHO of Fexinidazole Winthrop in African countries where T.b. rhodesiense is prevalent.

Price Action: SNY shares are down 0.62% at $47.94 during the premarket session on the last check Friday.

Photo Via Company