US FDA Expands Emergency Use Authorization for Remdesivir... Also Administered to Early-Stage Patients

Remdesivir
[Image source=Yonhap News]

[Asia Economy Reporter Lee Gwan-joo] The U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for 'Remdesivir,' a treatment gaining attention for COVID-19.

On the 28th (local time), American pharmaceutical company Gilead Sciences released a press statement announcing, "With the FDA's expansion of the EUA for Remdesivir, it can now be prescribed to all patients hospitalized with COVID-19."

Merdad Parsey, Gilead's Chief Medical Officer (CMO), said, "We welcome the FDA's decision to expand the EUA," adding, "Research on the effectiveness of Veklury (the brand name for Remdesivir) is also progressing." He further explained, "It has been confirmed to be effective for patients in the early stages of the outbreak as well," and "It will be possible to prescribe it to more patients."

On the 21st of this month, Gilead published the results of the Phase 3 clinical trial of Remdesivir in the Journal of the American Medical Association (JAMA). Gilead divided 397 COVID-19 patients into an experimental group receiving Remdesivir for 5 or 10 days and a control group not receiving the drug, evaluating health status using a 7-level ordinal scale. The results showed that patients in the experimental group who received Remdesivir for 5 days had a 65% higher probability of symptom improvement compared to the control group. There was no statistically significant difference between the experimental groups receiving Remdesivir for 10 days and 5 days.

The probability of death within 28 days after administration was less than 2% for patients in the experimental group. However, regardless of the duration of administration, Remdesivir did not alleviate symptoms such as nausea, diarrhea, hypokalemia, and headache.

Originally developed as an Ebola treatment, Remdesivir showed positive results in clinical trials involving hospitalized COVID-19 patients and received FDA Emergency Use Authorization in May of this year. South Korea has also imported Remdesivir through special importation since July and is administering it to severe COVID-19 patients.

This content was produced with the assistance of AI translation services.