BREAKING NEWS: Gilead’s remdesivir gets FULL FDA approval as a treatment for coronavirus patients
- On Thursday, the FDA gave full approval for the antiviral drug remdesivir as a treatment for the novel coronavirus
- Previously, it was the only medication approved in the US to treat COVID-19 patients by emergency use
- A recent NIH study found remdesivir shortened coronavirus hospital stays by five days and reduces the risk of death by 30%
The US Food and Drug Administration (FDA) has given full approval to the antiviral drug remdesivir as a coronavirus treatment.
Manufactured by California-based Gilead Sciences Inc, the medication was the only approved for emergency use in the US to treat severely ill COVID-19 patients.
It was also one of among a cocktail of drugs used to treat President Donald Trump when he contracted the virus earlier this month.
According to the FDA’s website says the drug has been approved in two forms: five milligrams (mg) per milliliter dropper and 100 mg per vial.
A recent study from the National Institutes of Health found that remdesivir shortened coronavirus hospital stays by five days and reduces the risk of death by 30 percent.
On Thursday, the FDA approved the antiviral drug remdesivir (pictured) as a treatment for coronavirus patients
Remdesivir was developed by Gilead Sciences to treat Ebola, the deadly hemorrhagic fever that emerged in West Africa in 2014.
It works by blocking an enzyme that helps the coronavirus make copies of itself and, in turn, spread throughout the body.
In cell and animal models, studies showed the drug blocked the activity of Severe Acute Respiratory Syndrome (SARS) and MERS (Middle East Respiratory Syndrome), which are cousins of the new virus.
Dr John Beigel, associate director for clinical research in the Division of Microbiology and Infectious Diseases at the NIH’s National Institute for Allergy and Infectious Diseases (NIAID), said the drug prevents the virus from replicating, which helps the patient ‘get ahead’ and fight off the infection because it is not ‘as rampant.’
A recent study published last month, which Beigel co-authored, found the drug reduced the recovery time for hospitalized coronavirus patients from a median of 15 days to 10 days.
Additionally, about 11 percent of patients in the remdesivir group died compared to around 15 percent in the control group.
This show the drug reduced the risk of death by 30 percent.
The team said the benefit of remdesivir was largest when given earlier in the illness, but it was still seen for those that received it later.
‘In fact, the study showed there was still benefit. Even people that came in quite late, after 10 days [of illness], they still had benefit from resdesivir,’ Beigel told DailyMail.com in a recent interview.
‘It wasn’t as strong. Getting treatment early is still a benefit, but there was clear benefit for those that came in 10 days or more also ‘
This is a breaking news story and will be updated.