Sanofi’s Fexinidazole Winthrop gets positive opinion from CHMP

Sanofi’s all-oral sleeping sickness drug Fexinidazole Winthrop (fexinidazole), that could transform the treatment of trypanosomiasis, has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use who reviewed it under the Article 58 mechanism. This regulatory procedure allows the CHMP to assess the quality, safety and efficacy of medicines and give opinions on it for use in low to middle income non EU countries. If full approval is granted, the drug will be the first oral treatment available for this disease, most intensely affecting the people of central Africa, and usually fatal if left untreated. Fexinidazole Winthrop was evaluated in three clinical studies involving 749 patients across the different stages of the disease. The studies showed high cure rates in patients after ten days of treatment, especially in the earlier stage of the disease. The most common side effects observed were vomiting, nausea, headache, insomnia, weakness, dizziness and tremor.
The EMA said: “Fexinidazole Winthrop, as exclusively oral treatment regimen for the disease, could potentially allow quicker and wider access to treatment because distribution and administration of tablets is easier.”