Fexinidazole Winthrop - opinion on medicine for use outside EU
fexinidazole
EU-M4allHuman
Overview
Fexinidazole Winthrop is a medicine for treating sleeping sickness (African trypanosomiasis) caused by Trypanosoma brucei gambiense and T. brucei rhodesiense parasites. It is intended for use outside the EU.
Sleeping sickness occurs in some parts of Africa and is spread through the bite of tsetse flies infected by Trypanosoma parasites. In the first few days after being bitten, patients may have symptoms such as fever, headache and rash. Later, they may experience a more severe form of the disease, which affects the nervous system, causing symptoms such as sleep disturbances and changes in behaviour. Without treatment, the disease is usually fatal.
Fexinidazole Winthrop is for patients who are 6 years or older and weigh more than 20 kilograms. It contains the active substance fexinidazole.
Fexinidazole Winthrop is available as tablets to be taken once a day with food for 10 days.
Treatment should be supervised by trained healthcare staff who should ensure that the patient takes the tablets as required and with food. For more information about using Fexinidazole Winthrop, see the package leaflet or contact your healthcare provider.
The active substance in Fexinidazole Winthrop, fexinidazole, is believed to work by activating certain enzymes within the parasites, which then produce substances known as reactive amines. These substances are toxic to the parasites and can help clear them from the body.
A main study in 394 patients with sleeping sickness affecting the nervous system showed that Fexinidazole Winthrop was effective at clearing T. brucei gambiense parasites from the body in 91% of patients 18 months after treatment.
In this study, Fexinidazole Winthrop was less effective in patients with severe disease than the standard treatment – nifurtimox eflornithine plus combination therapy (NECT) – which had a success rate of 98%. However, Fexinidazole Winthrop (which is taken by mouth) is easier to use than NECT, which requires infusions (drips) into a vein in addition to treatment by mouth.
In another study in 230 patients with less severe sleeping sickness caused by T. brucei gambiense infection, the success rate with Fexinidazole Winthrop was 99% 12 months after the end of treatment.
In another main study involving 45 patients with sleeping sickness caused by T. brucei rhodesiense, 35 of whom with more severe disease, no patients treated with Fexinidazole Winthrop died due to disease or treatment complications while they were hospitalised. This compares with a historical average of 8.5% of patients dying seen in an observational study and the medical literature when patients are treated with melarsoprol, another medicine for this disease.
For the full list of side effects and restrictions with Fexinidazole Winthrop, see the package leaflet.
The most common side effects with Fexinidazole Winthrop (which may affect more than 1 in 10 people) include vomiting, nausea (feeling sick), weakness, loss of appetite, headache, difficulty sleeping, tremors and dizziness.
Fexinidazole Winthrop must not be used in patients who are hypersensitive (allergic) to fexinidazole or any medicines of the same class or to any of the ingredients in the medicine. It must also not be used in certain patients with signs of liver problems or those at risk of heart rhythm problems.
Fexinidazole Winthrop is effective at eliminating the parasites that cause sleeping sickness. Although it is less effective against severe forms of the disease than NECT, the standard treatment for the disease caused by T. brucei gambiense, Fexinidazole Winthrop could be made available more easily to patients in parts of Africa where the illness occurs.
As for its safety, side effects such as vomiting are generally manageable. Certain patients at risk of side effects, such as patients with pre-existing heart rhythm problems, will not be given this medicine.
The European Medicines Agency therefore concluded that Fexinidazole Winthrop’s benefits are greater than its risks in patients with sleeping sickness.
Recommendations and precautions to be followed by trained healthcare staff and patients for the safe and effective use of Fexinidazole Winthrop have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Fexinidazole Winthrop are continuously monitored. Side effects reported with Fexinidazole Winthrop are carefully evaluated and any necessary action taken to protect patients.
The European Medicines Agency gave a positive opinion for Fexinidazole Winthrop on 15 November 2018.
The Agency assessed Fexinidazole Winthrop as part of its cooperation with the World Health Organization, whereby the Agency evaluates medicines that are not intended for use in the EU but are needed to prevent or treat diseases of major public health importance around the world.
Product information
Latest procedure affecting product information: II/0016
14/12/2023
Product information documents contain:
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturer responsible for batch release
- Annex IIB - Recommendations to the opinion holder - conditions of use
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Pharmacotherapeutic group
- Antiparasitic products, insecticides and repellents
- Antiprotozoals
- Agents against leishmaniasis and trypanosomiasis
- Nitroimidazole derivatives
Therapeutic indication
Fexinidazole Winthrop is indicated for the treatment of both first-stage (haemo-lymphatic) and second-stage (meningo-encephalitic) of human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense (g‑HAT) and Trypanosoma brucei rhodesiense (r-HAT) in adults and children ≥ 6 years old and weighing ≥ 20 kg. Fexinidazole should be used in line with official recommendations (see section 4.4).
Opinion details
Product details
- Name of medicine
- Fexinidazole Winthrop
- EMA opinion number
- H-W-2320
- Opinion status
- Positive opinion
- Active substance
- fexinidazole
- International non-proprietary name (INN) or common name
- fexinidazole
- Therapeutic area (MeSH)
- Trypanosomiasis, African
- Anatomical therapeutic chemical (ATC) code
- P01CA03
Publication details
- Opinion holder
- Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France - Date of opinion