Food & Drug Administration approves commercial use of remdesivir for covid on 22 October 2020

 Report by : Gan Yung Chyan, KUCINTA SETIA

Image : Web Screenshot (Shutterstock)

Food & Dug Administration (FDA) of the United States has approved commercial use of remdesivir for covid on 22 October 2020. Remdesivir is marketed by Gilead Science Inc under the name Veklury.

According to the FDA's press release, Veklury is authorized 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.

Important information about using Veklury to treat COVID-19 for its approved use is available in the prescribing information which includes dosing instructions, potential side effects and drug interactions. 

Possible side effects of consuming Veklury include increased levels of liver enzymes, which may be a sign of liver injury, and allergic reactions, which may include changes in blood pressure and heart rate, low blood oxygen level, fever, shortness of breath, wheezing, swelling (e.g., lips, around eyes, under the skin), rash, nausea, sweating or shivering. 

Similar safety information about using Veklury to treat COVID-19 in certain hospitalized pediatric patients under the EUA is available in the fact sheets for hospital, patients and caregivers.

According to CBS News, the label on Veklury warns against using it with the drug hydroxychloroquine because "that can curb its effectiveness".

President Trump took doses of remdesivir when he suffered from covid and was hospitalized from 2 to 5 October 2020. He recovered after receiving Regeneron''s antibody cocktail treatment. He said severe covid patients in America will undergo antibody cocktail treatment for free once FDA has approved the treatment.

In Singapore, Health Sciences Authority approves conditional use of Veklury on covid patients on 10 June 2020 and related official information is published on its web-site on 17 September 2020, which states "As a guide, the total duration of treatment is up to ten days in patients under IMV or ECMO, up to five days in patients who are not under IMV or ECMO, and up to ten days if these patients do not improve. As no studies in children and pregnant women were presented to HSA, no recommendation for use were made in these special populations."

IMV is short for invasive mechanical ventilation, which involves any instrument inside the trachea through the mouth, such as an endotracheal tube or the skin, such as a tracheostomy tube.

ECMO is short for extracorporeal membrane oxygenation. Known also as extracorporeal life support, ECMO is an extracorporeal technique of providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of gas exchange or perfusion to sustain life.

Refs:

FDA's Press Release : FDA Approves First Treatment for COVID-19, https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

FDA approves first COVID_19 drug, remdesivir, https://www.cbsnews.com/news/fda-approves-first-covid-19-drug-remdesivir/?fbclid=IwAR1MO0oUDRCfOGe_qCeqZ9FZXYpXr1nlDt3Il6urEGhAk3A72CizTJcmjAo

Conditional approval of remdesivir (Veklury) for COVID-19 infection in Singapore, https://www.hsa.gov.sg/announcements/safety-alert/conditional-approval-of-remdesivir-(veklury-)-for-covid-19-infection-in-singapore