FDA Administration approved the antiviral drug Remdesivir on the 22nd for the inpatient treatment of adult patients with Coronavirus and children over 12 years old and weighing over 40 kg. This is the first new Covid drug approved by the US Drug Administration.
Remdesivir is an antiviral drug developed by Gilead Technology, USA, originally used to treat diseases such as Ebola hemorrhagic fever and Middle East respiratory syndrome. The US Drug Administration said in a statement that Redcivir can only be used in hospitals or nursing facilities that can provide similar inpatient treatment.
The statement stated that when considering the approval of a drug, the U.S. Drug Administration will conduct a risk assessment based on strict scientific standards to ensure that the benefits of the drug outweigh the risks. The decision to approve the use of Remdesivir in the treatment of Coronavirus was made after analyzing the data of three randomized double-blind controlled trials for hospitalized patients with mild to severe new Corona.
According to the U.S. Drug Administration, the first trial recruited a total of 1062 patients with mild, moderate and severe Coronavirus to participate. They were assigned to the treatment group and control group to receive remdesivir and placebo treatment. The results showed that the median recovery time was 10 days in the treatment group and 15 days in the placebo group. The percentage of clinical symptoms improved on the 15th day in the treatment group was also higher.
The second trial compared the effects of patients who were hospitalized with moderate new coronary disease after receiving 5-day and 10-day remdesivir treatment with patients who received only general care. The researchers’ evaluation on the 11th day of patients’ treatment showed that the proportion of patients in the 5-day treatment group was significantly improved compared to those in the general care group, while the 10-day treatment group had more symptom improvements than those in the general care group, but there was no statistically significant improvement. Significant differences.
The third trial compared the effects of severely ill hospitalized patients with COVID-19 after receiving 5-day and 10-day remdesivir treatment. Researchers’ evaluation results on the 14th day of treatment showed that the two groups of patients had similar improvement in symptoms, and there was no statistically significant difference in recovery rate or mortality.
According to the US Drug Administration, the possible side effects of using Redcivir include increased liver enzyme levels and allergic reactions, such as changes in blood pressure and heart rate, hypoxemia, fever, shortness of breath, wheezing, redness and swelling of the lips or eyes, and rash , Nausea, sweating or shaking.
In May of this year, the US Drug Administration authorized US medical institutions to “emergency use” remdesivir when treating severely ill patients with new coronary disease. However, emergency use authorization does not equate to formal approval.
The interim results of the Corona “solidarity trial” released by the World Health Organization in mid-October showed that therapies such as remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon seem to have an effect on the 28-day mortality of hospitalized patients or the Coronavirus The patient’s hospitalization has little or no impact.