Remdesivir drug receives approval as a treatment medicine for COVID-19 patients.
The US Food and Drug Administration (FDA) approves the use of Remdesivir for the treatment of COVID-19 positive patients in hospitals. In the country, the drug has been in use since May but under emergency conditions. In the latest statement given by FDA, it fully approves the use of the remedy in hospitals.
Veklury, the drug’s brand name, is the first to receive approval for treating COVID-19 patients. However, the studies conducted by the World Health Organization showed different results.
Controlled clinical trials and rejections
Last week, the World Health Organization said that the Remdesivir had little or no effect on the patient’s survival. The results were based on the organization’s own trials.
When the findings were bought to the attention of its manufacturer Gilead Sciences, a biotechnological company, they rejected it.
Further, in the FDA’s statement on Thursday, it directs the use only for adult and pediatric patients 12 years of age and older. Additionally, it also mentioned that the individuals’ weight should be above 40 kilograms or 88 pounds.
The drug will be utilized only on patients requiring hospitalization. FDA Commissioner Stephen Hahn commented:
“Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic.”
The controlled clinical trial was carried out on three random patients. All of them are hospitalized with COVID-19 symptoms ranging from mild to severe.
The study showed that the patients who were administered the antiviral drug recovered within 10 days, and the others who didn’t, took 15 days.
Separate research by WHO
In individual research conducted by WHO, there was no significant improvement in the patient’s health after introducing Remdesivir. It also included other drugs like hydroxychloroquine, used in the treatment of malaria, and a combination of lopinavir and ritonavir used to treat HIV.
The above-mentioned drug tests are carried out in 30 different countries, 500 hospitals, and 11,266 adult patients. Currently, Dexamethasone, a low-cost steroid drug, is used for COVID-19 intensive care patients in the UK. This is not included as a part of the study.
However, the results obtained from the study are not peer-reviewed yet. Many believe that none of the treatments have a substantial effect on the death rate or the time of hospitalization of a COVID-19 patient. It is further argued that the methodology adopted by the WHO in the study is not conclusive.
The drug Remdesivir was also administered to President Donald Trump, following his COVID-19 diagnosis.
Image courtesy of Tobias Arhelger/Shutterstock