US approves emergency use of experimental drug remdesivir to treat COVID-19 patients

Remdesivir, an experimental drug developed by Gilead Sciences, Inc., a research-based biopharmaceutical company, has now been greenlit by American authorities for emergency use on serious coronavirus-affected patients in the US after clinical trials reportedly showed positive responses in severe COVID-19 patients. It is the first such drug shown to help fight COVID-19, which has affected around 11 lakh people in the US while killing nearly 65,000.

The Food and Drug Administration acted after preliminary results from a government-sponsored study showed that Gilead Sciences' remdesivir shortened the time to recovery by 31%, or about four days on average, for hospitalized COVID-19 patients. The study of 1,063 patients is the largest and most strict test of the drug and included a comparison group that received just usual care so remdesivir's effects could be rigorously evaluated.

US President Donald Trump announced the FDA's action at the White House. Those given the drug were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drug also might be reducing deaths, although that's not certain from the partial results revealed so far. The National Institutes of Health's Anthony Fauci said the drug would become a new standard of care for severely ill COVID-19 patients like those in this study.

Gilead has said that it would ramp up production for the drug. Currently, it is being administered intravenously (IV). Remdesivir will still need formal approval, news agencies reported, as no drugs had been approved until now for treating the coronavirus disease (COVID-19). The FDA previously gave emergency use authorization to a malaria drug, hydroxychloroquine, after Trump repeatedly promoted it as a possible treatment for COVID-19.

Even as the number of deaths due to the coronavirus disease (COVID-19) pandemic outbreak continued to rise, several US states have started relaxing lockdown norms since Friday, in the wake of the experimental drug, remdesivir, being greenlighted by the American authorities for emergency use on patients. On Friday, Texas became the largest state yet to ease lockdown measures, although a substantial number of deaths continue to be recorded.

Remdesivir, which was originally tested in Ebola patients, has emerged as one of the top near-term hopes for COVID-19 patients. In addition to carrying out its own clinical trials, Gilead has made the drug available to studies run by other sponsors, as well as to more than 1,700 people on a compassionate use basis. Last month, the New England Journal of Medicine published data from 53 patients with severe disease, but that data set also lacked a control group.

Meanwhile, the COVID-19 tally in the United States has reached 11 lakh while the death toll due to the virus in the country has crossed 65,000, according to the Coronavirus Resource Center at the Baltimore-based John Hopkins University.

With a total number of 3.15 lakh cases, New York is the worst-affected state in the US. The state has also recorded an astonishing number of deaths. With 24,069 fatalities, New York accounts for more than 36% of the country's total death toll.

Next in the list of the worst-affected US states are New Jersey, Massachusetts, Illinois, California, Pennsylvania, Michigan, Florida. Texas, Connecticut, and Louisiana.

As the coronavirus disease (COVID-19) pandemic outbreak spreads like wildfire across the globe, the entire world is laying in anxious wait for a cure or a vaccine to combat the virus which has brought normal life to a standstill as almost the entirety of human race have been forced to go into self-isolation and home-quarantine as major cities remain in strict lockdown, all in fear of the virus.