Therapy Areas: AIDS & HIV
The FDA approves Veklury (remdesivir) as first treatment for COVID-19 in patients 12 years of age and older
23 October 2020 -

Public health agency The US Food and Drug Administration on Thursday authorised the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms for the treatment of COVID-19 requiring hospitalization.

Additionally, the agency has granted approval of Veklury (remdesivir) and reissued the revised EUA to Gilead Sciences Inc.

According to the agency, Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.

In conjunction, the clinical trials assessing the safety and efficacy of Veklury in the pediatric patients are ongoing, added the agency.

Veklury' approval was reportedly supported by the agency's analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.

The first randomized, double-blind, placebo-controlled clinical trial (ACTT-1) was conducted by the National Institute of Allergy and Infectious Diseases to evaluate how long it took for subjects to recover from COVID-19 within 29 days of being treated. A second randomized, open-label multi-center clinical trial of hospitalized adult subjects with moderate COVID-19 compared treatment with Veklury for five days and treatment with Veklury for ten days with standard of care. A third randomized, open-label multi-center clinical trial of hospitalized adult subjects with severe COVID-19 compared treatment with Veklury for five days and treatment with Veklury for ten days.

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