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Recently, the official website of the European Medicines Agency (EMA) announced that it has begun a rolling review of Merck’s oral new crown treatment drug Molnupiravir to assess the effectiveness, safety and quality of the drug
.
The European Medicines Agency stated that the decision to initiate the rolling review was based on preliminary results of laboratory and clinical studies
.
These studies show that monupivir can reduce the ability of the new coronavirus to reproduce in the body, thereby preventing the hospitalization or death of patients with new coronary pneumonia
Earlier, Merck said that it has applied to the FDA for emergency authorization of Molnupiravir
.
The FDA advisory group will meet at the end of November to discuss whether to approve the drug
Monupivir will be the first oral anti-coronavirus drug and the first drug to treat patients with mild COVID-19
On October 1 this year, Merck (Merck & Co.
) of the United States announced that the oral antiviral drug Molnupiravir developed by it and Ridgeback is safe and effective for the treatment of COVID-19
.
Merck and Ridgeback announced the phase III clinical interim data of Molnupiravir in the treatment of patients with mild to moderate new coronary pneumonia.
Merck also emphasized that Molnupiravir has been proven to target multiple types of new coronaviruses, and that SARS and MERS have positive effects in the prevention, treatment and prevention of the spread of the virus.
This means that Merck’s oral new crown treatment drugs are difficult for the current global epidemic prevention and control.
The problem of virus mutation also has a better performance
.
In terms of safety, Merck said that the incidence of all adverse events in the monupivir group and the placebo group was equal, 35% and 40%, respectively
.
Similarly, the incidence of drug-related adverse events is also comparable, at 12% and 11%, respectively
At present, Merck has signed a non-exclusive voluntary license agreement for monupivir with mature generic drug manufacturers to accelerate the supply after obtaining marketing approval or emergency use authorization in more than 100 low- and middle-income countries
Reference materials:
Reference materials:[1]https://baijiahao.
[1]https://baijiahao.
[2]https://baijiahao.
baidu.
com/s?id=1712678094132198288&wfr=spider&for=pc
