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The National Medicines Agency and the High Health Authority (HAS) have announced their refusal to authorize the drug Xav-19 to the Nantes laboratory Xenothera. A blow for the French biotech which announces, in a press release, to continue its research.
What is Xav-19?
According to the Xenothera laboratory, XAV-19 is a “polyclonal antibody, having the ability to block the Omicron variant“. This is a treatment based on a “humanized” porcine antibody, dedicated to patients with moderate COVID-19, expected to block the passage to a severe form of the disease and the transfer to the intensive care unit.
However, according to the ANSM, which studied the data related to the molecule, “the efficacy and safety of this medicinal product in the indication considered were not strongly presumed”.
The negative opinion of the health authorities
In order to continue its studies on this potential treatment, the company had submitted a file containing the first results of their treatment to the health authorities. But it is a negative opinion issued by the High Authority for Health (HAS) on January 28.
The conclusion of the National Medicines Agency (ANSM) judges that “clinically, in view of the data transmitted in the initial dossier and the additional data transmitted following requests for information made by HAS, there is currently no objective evidence to demonstrate the therapeutic benefit of Xav-19 in the indication claimed by the laboratory and according to the proposed dosage schedule”.
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Xenothera continues its research
The Nantes biotechnology company Xenothera does not give up and announces in a press release on Monday the continuation of its research on its treatment. And its president Odile Duvaux emphasizes that “although the data available is limited” Xenothera wished “to have the opinion of the authorities to see if they would agree to consider the interest of the product”. She concludes by stating that “in accordance with their advice, Xenothera will proceed with its European trial”to complete the file of the XAV-19 whose interest remains intact” .