First-ever all-oral drug for sleeping sickness recommended for approval by EMA committee
pharmafile | November 20, 2018 | News story | Manufacturing and Production, Sales and Marketing | CHMP, EMA, Europe, Sanofi, fexinidazole, pharma, sleeping sickness
Sanofi’s fexinidazole, the first all-oral therapy for the treatment of human African trypanosomiasis (HAT), or sleeping sickness, has secured a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP), the manufacturer has said. If approved, the drug could hit markets in endemic countries next year.
The decision was based on data derived from a trial of 749 patients, showing that the drug was effective in both stages of sleeping sickness in both adult and paediatric patients after ten days of treatment, and could also help to reduce lumbar punctures and prevent systematic hospitalisation.
“This therapeutic breakthrough is the latest milestone in Sanofi’s long-term commitment to sleeping sickness,” commented Sanofi’s Chief Medical Officer Ameet Nathwani. “Fexinidazole is the proof that partnerships between public and private sectors can deliver safe and effective medicines for the most neglected patients.”
Sleeping sickness is tropical disease endemic in sub-Saharan Africa, which is characterised by bouts of fever, headaches, itching and joint and muscle pains, as well as mental confusion, slurred speech and seizures, and can ultimately result in death within two or three years if untreated.
The CHMP’s recommendation is not binding, but it will be a considerable factor in the final decision from the EMA to approve or reject Sanofi’s therapy in the coming months.
Matt Fellows
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