FDA Approves First Treatment for COVID-19

covid virus
This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. Note the spikes that adorn the outer surface of the virus, which impart the look of a corona surrounding the virion, when viewed electron microscopically. A novel coronavirus, named Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China in 2019. The illness caused by this virus has been named coronavirus disease 2019 (COVID-19).

Yesterday, October 22, 2020 the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. 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. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.

See FDA Approves First Treatment for COVID-19.

This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing.

For additional information on the authorized use of Veklury under the EUA, refer to the Fact Sheet for Healthcare Providers

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We all want to head off to exciting destinations, but our job now both as health professionals and as responsible citizens is to defeat COVID.  To those of you on the front lines of patient care, we applaud you and are very grateful for your service.  For those who have the luxury to stay home or work remotely, do so and wear a mask when you leave home. COVID may be changing the way we interact with each other, but we still have a beautiful planet to explore.  In the interim, we have many live online and recorded online continuing education options for you. 

Until we meet again. Stay safe.