Ivermectin (illustration). – Fotoarena / Sipa USA / SIPA
A request for temporary authorization to use ivermectin, an antiparasitic drug, to treat or prevent Covid-19, has been rejected by the French Medicines Agency ANSM.
The health agency, which publishes its decision Thursday, had been seized on this subject by Me Jean-Charles Teissedre, representing an association and health professionals.
No clinical benefit established to date
“Due to the data available to date, we cannot respond favorably” to this request for temporary authorization (called “RTU”), notes the ANSM.
The analysis of the published data, “due to their methodological limitations, does not make it possible to support a clinical benefit of ivermectin whatever its context of use, in curative treatment or in prevention of Covid-19 disease” .
However, the ANSM underlines “the need to implement large scientifically rigorous clinical studies” in order to conclude that it can be used in the context of Covid-19 disease “.
Ivermectin is the subject of intense promotion on social networks.
Not recommended for use outside of clinical trials
The European Medicines Agency (EMA / EMA) and WHO on March 22 and March 31, respectively, recommended not to use it for Covid-19 outside of clinical trials. An opinion was also issued in this direction in France, on February 27, by the High Council of Public Health (HCSP).
However, the EMA mentioned in its opinion that the Czech Republic and Slovakia have allowed temporary use of ivermectin in connection with the coronavirus.
The ANSM indicates that it will be able to revise its position, as soon as the results of clinical studies are likely to modify the finding established to date. In the meantime, her decision “may be subject to an appeal for annulment before the Council of State within two months of its receipt,” she wrote to the lawyer.