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Fexinidazole: First Global Approval.

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  • 1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.

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Summary
This summary is machine-generated.

Fexinidazole is a new oral treatment for human African trypanosomiasis (HAT), also known as sleeping sickness. This drug, fexinidazole, has received a positive opinion from the EMA for treating both stages of HAT in children and adults.

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Area of Science:

  • * Pharmacology and Tropical Medicine
  • * Drug Development and Regulatory Affairs

Background:

  • * Fexinidazole is a 5-nitroimidazole derivative developed for treating neglected tropical diseases.
  • * It targets Human African Trypanosomiasis (HAT) and Chagas' disease, caused by Trypanosoma parasites.
  • * The Drugs for Neglected Diseases initiative (DNDi) identified its potential in 2005.

Purpose of the Study:

  • * To summarize the development milestones of fexinidazole.
  • * To report the positive opinion granted by the European Medicines Agency (EMA) for fexinidazole in treating Human African Trypanosomiasis (HAT).

Main Methods:

  • * Review of drug development data and regulatory submissions.
  • * Evaluation under Article 58 of Regulation (EC) no. 726/2004 for medicines outside the EU.
  • * Ongoing Phase 3 clinical trials for HAT and development for Chagas' disease.

Main Results:

  • * Fexinidazole received a positive EMA opinion for treating both stages of HAT (gambiense HAT) in adults and children (≥6 years, ≥20 kg).
  • * This facilitates marketing authorization applications in endemic countries.
  • * Fexinidazole will be distributed via the WHO for HAT treatment.

Conclusions:

  • * Fexinidazole represents a significant advancement in the oral treatment of HAT.
  • * The EMA's positive opinion marks a crucial step towards wider accessibility of this treatment.
  • * Further development is ongoing for Chagas' disease, while development for visceral leishmaniasis has been discontinued.