It was to be available in France from the fall of 2021: XAV-19 was designed as a drug for patients suffering from moderate Covid-19 and was to be used to prevent the worsening of the disease.
Very promising, XAV-19 (developed by a biotechnology laboratory based in Nantes: Xenothera) worked on the basis of polyclonal antibodies supposed to imitate the body’s immune response to “attack” the SARS-CoV-2 coronavirus. At the end of 2021, the French State had undertaken to buy 30,000 doses, subject to validation by the health authorities.
“The therapeutic interest of polyclonal antibodies” is not demonstrated, for the ANSM
Yes, but here it is: this Friday, January 28, 2022, the National Agency for Medicines and Health Products (ANSM) rejected the request for authorization of XAV-19 for lack of “therapeutic interest“…
“At this stage, the data provided by the laboratory do not allow clinical demonstration of the therapeutic interest of polyclonal antibodies. [contre le Covid-19]” justifies the ANSM which adds that “additional data will be needed to assess the benefit of this treatment for patients with Covid-19“.
A blow for the Xenothera laboratory which had published the results of the first phase of the XAV-19 clinical trial (which was carried out on 398 patients in 35 French hospitals) in April 2021: at the time, these were found to be very encouraging. And at the end of December 2021, Nantes researchers even claimed that XAV-19 would be effective against the Omicron variant.
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