Sanofi, DNDi And The HAT-r-ACC Consortium Announces That European Medicines Agency Has Given Positive Opinion To Fexinidazole Winthrop As First Oral Treatment Of Acute Form Of Sleeping Sickness Found In East And Southern Africa
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The European Medicines Agency (EMA) has given a positive opinion to Fexinidazole Winthrop, developed by Sanofi, DNDi, and the HAT-r-ACC consortium, as the first oral treatment for the acute form of sleeping sickness (rhodesiense) in East and Southern Africa. This treatment is applicable for adults and children six years and older, weighing at least 20 kg. The CHMP's positive opinion is based on clinical trials in Malawi and Uganda and follows a previous positive opinion for the treatment of the T.b. gambiense form of sleeping sickness in 2018.
December 15, 2023 | 7:37 am
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POSITIVE IMPACT
Sanofi's Fexinidazole Winthrop receives positive opinion from EMA for treating acute sleeping sickness, potentially enhancing Sanofi's product portfolio and reinforcing its position in tropical disease treatments.
The positive opinion from the EMA is a significant regulatory milestone for Sanofi, likely to lead to increased interest in the company's shares in the short term. This development could enhance Sanofi's reputation in the pharmaceutical industry, particularly in the field of neglected tropical diseases, and may lead to future revenue growth as the treatment becomes available in the market.
CONFIDENCE 85
IMPORTANCE 75
RELEVANCE 90