The U.S. Food and Drug Administration (FDA) today approved the antiviral drug Remdesivir of Gelia Pharmaceuticals for the treatment of hospitalized patients with coronavirus disease. This was making Remdesivir the first and only approved for the disease drug.
Gilead Sciences Inc. stated that it is currently meeting patients’ immediate demand for Remdesivir; Remdesivir is sold in the United States under the trade name Veklury. Besides that, it is expected to meet global demand by the end of October.
The FDA previously authorized remdesivir for the treatment of coronavirus disease 2019 (COVID-19). It is also one of the drugs that infected US President Trump.
U.S. Food and Drug Administration (FDA)
U.S. Food and Drug Administration approves remdesivir for the treatment of hospitalized patients with a new crown.
A large study led by the National Institutes of Health showed that after remdesivir shortened the hospital stay by 5 days. It has become the standard drug for patients with severe coronary disease.
World Health Organization (WHO)
However, the World Health Organization (WHO) pointed out last week that remdesivir has little or no effect on the mortality of hospitalized patients. Moreover, it cannot help patients recover faster. This research has not been reviewed by external experts.
After the news came out, US stocks Gilead Sciences rose more than 5% after the market, and the company’s shares closed up 0.76% on Thursday to $60.67.
It is worth noting that the WHO has previously stated that remdesivir and others have little effect on improving the mortality rate of hospitalized patients with new coronary pneumonia.
These data come from a biological randomized double-blind placebo-controlled Phase 3 study led by the National Institute of Allergy and Infectious Diseases (NIAID), covering approximately 1,060 hospitalized patients worldwide. The data shows that the average recovery time of inpatients treated with Veklury was five days faster, while those with severe illnesses took seven days, and these seriously ill patients accounted for 85% of the total number of studies.
Remdesivir is officially authorized by the FDA
In May of this year, the FDA approved the emergency use authorization of Remdesivir. So that hospitals and doctors can use the drug in severely ill patients hospitalized with new coronary pneumonia. The intravenous drug helped shorten the recovery time of some hospitalized patients with new coronary pneumonia.
Gilead Sciences said in August that it plans to produce more than 2 million courses of remdesivir by the end of the year. Furthermore, expects to “add several million” to the production of the drug by 2021. The supply of the drug has increased 50 times since January. Now, more than 40 companies including North America, Europe and Asia are manufacturing this medicine.
WHO Director-General Tedros Tedros said just last week that the interim results of the “Unity Trial” showed that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon treatment are preventing the death or shortening of patients with new coronary pneumonia. There is little effect on the length of hospital stay.
The “Unity Trial” will evaluate other therapies, including monoclonal antibodies and new antiviral drugs. At present, dexamethasone is still the only effective drug for severe patients with new coronary pneumonia.
Fauci, director of the National Institute of Allergy and Infectious Diseases of the United States, said that Gilead’s scientific data show that Redecive has a significant positive effect on anti-virus. Moreover, “sets a new standard of treatment” for patients with new coronary pneumonia.
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