US FDA approves 'Remdesivir' as first treatment for COVID-19!

Gilead Sciences announced that remdesivir got the full approval from the Food and Drug Administration as coronavirus treatment.

Remdesivir from Gilead Sciences (Photo by Ulrich Perrey/Pool from Reuters)

Shortening the recovery time in some patients

The said drug is currently sold under the brand name Veklury. It has been authorized for emergency usage since May this year. Since then, the antiviral drug reportedly shown modest benefit on patients.

The drug manufacturer Gilead Sciences stated that Veklury was prescribed for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. It added,

Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. 

Prior to the approval, a global research sponsored by WHO discovered that remdesivir did not help patients survive or even heal faster. However, a study conducted in the US recognized that the infused drug made the recovery time shorter for some patients by about one third of the time projected.

During the approval phase, Gilead Sciences did a submission of a study published in the New England Journal of Medicine. The research showed that remdesivir was able to shorten the recovery phase from 15 days to 11 days in hospitalized patients.

Aside from that, FDA also reviewed two other studies before considering this drug. One showed a slight benefit of the drug and another showed the drug did not make much difference.

On the other hand, the former director of the Biomedical Advanced Research and Development Authority (BARDA) said that remdesivir is not an impressive drug at all. He emphasized to a source that the drug only gave modest benefit.

However, FDA Commissioner Dr. Stephen Hahn stated that the approval is backed up by data from several clinical trials by their agency. It represents a significant scientific milestone in the pandemic.

 

FDA will still continue with Coronavirus Treatment Acceleration Program to seek new medical products for patients as soon as possible. At the same time, they will still determine the effectivity and if their benefits offset the risks.

What are your thoughts on this approval?

Sources: FDA, CNN

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