This is a blow for the promising Nantes biotech. The Medicines Agency (ANSM) has rejected the request for authorization of synthetic antibodies against Covid-19, produced by the French company
Xenothera, she said on Friday. The Nantes-based laboratory had requested authorization for its drug Xav-19 in the treatment of “moderate lung damage due to Covid-19”. The treatment of the French biotech Xenothera, created in 2014, consists of synthetic antibodies, called “polyclonal antibodies”. Its product, Xav-19, is based on antibodies of porcine origin modified to be “humanized”.
“At this stage, the data provided by the laboratory do not allow clinical demonstration of the therapeutic interest of polyclonal antibodies” for this indication, writes the agency, according to which it is not proven that the benefit-risk ratio is positive. . “Additional data will be necessary to assess the benefit of this treatment for patients with Covid-19 and to specify its tolerance profile,” she said.
The Paxlovid available in February
The Medicines Agency also confirms that following the marketing authorization for Paxlovid by the European Commission, this treatment would be available in France in February under an early access authorization. This anti-Covid pill from the manufacturer Pfizer should be given to patients within five days of the onset of symptoms.
Studies have indicated that this treatment significantly reduces hospitalizations or deaths in patients at risk of developing severe disease, and should remain effective against the Omicron variant.