Gilead’s Remdesivir Gets FDA Approval

On Friday, President Trump announced that the remdesivir, an antiviral treatment developed by Gilead Sciences, had been authorized by the Food and Drug Administration (FDA) as an emergency treatment for the Covid-19. The announcement was made in the Oval Office with the Gilead CEO Daniel O’Day in attendance.

According to O’Day, Gilead would be donating 1.5 million vials of remdesivir. He said this after appreciating everyone that has been a part of the Gilead team responsible for developing the treatment.

The authorization of this emergency drug allows that the drugs be directly distributed to doctors and other recognized healthcare givers to administer to drugs to patients with severe cases of the Covid-19. This includes Covid-19 patients with low blood oxygen or those that require ventilators to provide breathing assistance.

Following the announcement, Gilead shares showed potentials of rising on the news; though, still closed down 4.8% at $79.5, on Friday. In extended trading, however, the stock rose nearly 2% in extended trading. In total, the company has gained 21% since January and currently has a market value of nearly $101 billion.

In spite of the FDA’s temporal approval of the drug as an emergency treatment for the Covid-19, it made some observations in its announcement, saying that: “There is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with Covid-19.”

The drug is still yet to undergo proper review as an FDA-approved treatment, according to a fact sheet from the agency. However, it has granted approval to doctors to use the drug on hospitalized patients as further research is done on it. Prior to that, the FDA approved the emergency use of malaria drugs, chloroquine, and hydroxychloroquine to treat Covid-19, but later issued a warning against using it outside hospital settings. The FDA released the warning based on reports it had received about the drugs causing “serious heart rhythm problems” in the patients.

The remdesivir was originally developed to treat Ebola, however, it has also been experimented on other coronaviruses like the SARS and MERS. The positive progress Gilead got from experimenting remdesivir spurred it to join in the race of the Covid-19 treatment. An unauthorized report was released last week on the progress of the drug during clinical testing on 125 patients. The results from the National Institute of Health (NIH) also revealed that Covid-19 patients who were treated with remdesivir during clinical trials experienced a 31% recovery faster than the other patients on placebo.

The NIH trial, called the Adaptive COVID-19 Treatment Trial, had in total 1,063 patients. According to the trial results, the average recovery time for patients on the placebo treatment was 15 days, while patients receiving the remdesivir treatment had an average recovery time of 11 days. It was also discovered that the remdesivir also lowered the mortality rate by 11.6%, compared to placebo’s 8%.

Gilead also conducted an internal study, examining 397 patients. The patients were divided into groups and treated with the remdesivir over five days and over ten days. By the end of the study, the results showed that there was little difference between the groups. Revealing that the drug was as effective over five days as it was over ten days.  Although, the study didn’t include a group for the placebo treatment.

Though the drug may have made steady progress in the past week and gained the approval of the FDA as an emergency drug for the Covid-19, its full effectiveness is still yet to be known. Around the same time, clinical trials of the drug were being run in the United States, they were also run in China. However, China eventually stopped the use of the remdesivir for clinical trials. A report was recently published in the Lancet, showing that there was no tangible benefit to taking the drug. Due to this, the drug is still under research even though the first batch will be dispersed for treatment.

If further research is carried out on the remdesivir, and it creates a positive reaction among all the patients it is used on, there is every possibility that it would become a fully authorized permanent treatment for the Covid-19.

Director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci told reporters at the White House last week (April 29) that the findings on the drug so far were “really quite important.” Further adding that “this will be the standard.”

President Trump, at a roundtable at the White House with business executives on Wednesday, said: “We would like to see very quick approvals, especially with things that work.”

There are currently about 20 studies on the remdesivir globally, to prove its effectiveness. Therefore, it may take a while until definitive results are produced on the effectiveness of the drug.

‘How does remdesivir work?’

The remdesivir is yet to be proven as an effective treatment for the Covid-19, however, the Gilead researchers are making headway. The drug works basically by preventing the virus behind the Covid-19 (SARS-CoV-2) from copying its RNA or genetic instruction set. These genetic instruction sets are written in a code made of molecules and are represented alphabetically as A, U, G, and C. The drug is designed to mimic the A (adenosine) molecule.

During an infection, the virus enzymes, in a bid to make copies of its RNA will mistake the remdesivir molecule for the adenosine. Once it copies the imitated molecule, the whole process comes to an immediate halt, so does the infection.