Source: yaozhi.com
Introduction: according to the latest clinical data, molnupiravir can only reduce the hospitalization rate or mortality by 30%.
On November 30, FDA pane voted 13:10 to approve the EUA application for molnupiravir, a new oral drug of MSD. If approved, as long as there is a doctor’s prescription, the confirmed patients or virus exposed persons can use the drug at home without going to the hospital or clinic for treatment like monoclonal antibody drugs.
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Molnupiravir is a new crown specific drug developed by mosadon in cooperation with Ridgeback biotherapy company. It has previously obtained emergency use authorization in the UK, but the latest published clinical data show that the effective rate has decreased significantly.
According to MSD’s announcement last week, the final test results showed that 68 people in the 699 placebo group were hospitalized or died, while only 48 of the 709 patients taking monapiravir had further deterioration, which reduced the risk of hospitalization / death from 9.7% to 6.8%, and the relative risk reduction ratio reached 30%. It is worth mentioning that 9 people died in the placebo group and only 1 in the molnupiravir group.
Nevertheless, the U.S. FDA expert committee voted 13 to 10 to support molnupiravir, an antiviral drug of methadone, saying that the benefits outweigh the risks. FDA is not obliged to follow the committee’s recommendations, but usually chooses to follow them.
In addition, Pfizer is also seeking FDA approval for its new crown drug. The phase III clinical study of paxlovid, a new crown oral drug, shows that the risk of hospitalization or death can be reduced by about 89% in patients with mild to moderate new crown within three days of diagnosis, which is comparable to the therapeutic effect of neutralizing antibody of new crown.
Responsible editor: Liuli
Post time: Dec-02-2021