Sanofi/DNDi's world's first full-oral drug fexinidazole has been approved

French pharmaceutical giant Sanofi recently announced that fexinidazole has been approved by the Democratic Republic of the Congo (DRC) for the treatment of The African Trypanosomiasis (HAT), commonly known as "sleeping sickness". The approval paves the way for fexinidazole to go public in popular countries. Sanofi has plans to submit a market application for the drug in Uganda.November 16, 2018, the European Medicines Agency (EMA) Committee on Human Pharmaceutical Products (CHMP) issued a positive opinion recommending the approval of fexinidazole. In a clinical study conducted at DNDi, fexinidazole showed high efficacy and safety for two stages of the disease in children aged 6 years and older and in children weighing ≥20 kg and adult patients. As a result, fexinidazole eliminates consistent hospitalization requirements and potentially reduces the number of lumbar punctures.is a deadly, neglected tropical disease spread by tsetse flies bites, which are often fatal if left untreated. Sleeping sickness can cause neuropsychiast symptoms, including debilitating damage to sleep patterns, unstotable attacks, and psychosis. It is estimated that some 65 million people are at risk in sub-Saharan Africa.current programme of treatment for sleeping sickness is effective, it is a logistical challenge for patients and health workers who need hospitalization, especially for people living in remote areas.fexinidazole has been approved as a 10-day, daily drug for the treatment of Buchy Gambian trypanosomiasis, the most common type of the disease, seen in West and Central Africa. Importantly, fexinidazole is the first full oral drug, both for the early stages of the disease and for the second stage of a disease in which parasites cross the blood-brain barrier causing neuropsychiastic symptoms in patients. As a result, fexinidazole eliminates the patient's consistent hospitalization needs.is a 5-nitromide derivative originally developed by Hoechst (Sanofi's predecessor) in the 1980s and later abandoned for strategic reasons. The drug was identified in 2005 in collaboration with the Swiss Institute of Tropical and Public Health during the search for compounds with anti-parasitic activity by the Neglected Disease Drug Development Organization (DNDi). In 2009, DNDi teamed up with Sanofi, which owns the patent for fexinidazole, to restart research on the drug to treat sleeping sickness. DNDi is responsible for preclinical, clinical and pharmaceutical development, while Sanofi is responsible for the industrial development, registration, production and sale of pharmaceuticals. (Bio Valley Bioon.com)original source:
Sanofi: Fexinidazole, the first all-oral treatment for sleeping sickness, approved in Democratic Republic of