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US: FDA approves Trump-touted COVID-19 treatment drug

Remdesivir given full green light after being granted emergency use authorization in May

Michael Gabriel Hernandez   | 23.10.2020
US: FDA approves Trump-touted COVID-19 treatment drug

WASHINGTON 

The US Food and Drug Administration (FDA) approved Thursday Gilead Sciences' Remdesivir as a treatment for those who have contracted the novel coronavirus.    

The drug has been touted by US President Donald Trump who received it earlier this month after contracting COVID-19 amid a flurry of public events and campaign activities.

The FDA had given Remdesivir an emergency use authorization as a potential COVID-19 treatment in May, and it was then put on a priority track for full approval.

Gilead said shortly after it was granted full approval for Remdesivir that the drug "is now the antiviral backbone of combination therapy" studies being reviewed by the National Institutes of Health.

"Beyond combination trials, we continue to study Veklury in specific populations, including pediatric patients, and in the outpatient setting, and we anticipate sharing data from these trials in the first half of next year," Dr. Merdad Parsey, the company's chief medical officer, said in a statement.

The drug will be used for COVID-19 patients who require hospitalization, and is administered intravenously.

While Remdesivir is approved for patients 12 years and older, Gilead said the FDA has issued a temporary emergency use authorization for it to treat younger individuals that weigh over 7.7 pounds.

The development comes as Moderna announced earlier Thursday it has enrolled 30,000 individuals in its phase three COVID-19 vaccine trial, meeting its metric for full enrollment with over one-third of participants being minorities.

About one-fifth of enrollees are Hispanic or Latino, and about 10% are Black.

“Completing enrollment of the Phase 3 COVE study is an important milestone for the clinical development of mRNA-1273, our vaccine candidate against COVID-19," Stephane Bancel, Chief Executive Officer of Moderna, said in a statement.


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