The drug agency (ANSM) has announced that a clinical trial evaluating an antirheumatic drug in France in the treatment of Covid-19 has been suspended due to unexplained excess mortality among treated patients according to preliminary trial results.
The drug agency said after “promising” results, he was suspended due to early excess mortality of treated volunteers.
According to a study by a French medical team from the Paris Saint-Joseph Hospital Group (GHPSJ), published in the specialized journal The Lancet Rheumatology, this drug marketed under the name Kineret, had given “encouraging” results for severe forms of the disease. Covid-19 disease by significantly reducing the risk of death and the need to be put on a ventilator in intensive care.
According to the ANSM, this safety information does not call into question the benefit / risk ratio of anakinra when it is used in the validated indications of its marketing authorization (AMM) such as for example for the rheumatoid arthritis.
The health agency also clarified that other clinical trials with anakinra authorized in France in the Covid-19 indication are also suspended. However, these clinical trials were already stopped or had not yet started, specifies the ANSM.
Ibtihal Bassir / Le7tv.
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