US FDA approves first COVID-19 treatment drug - Veklury (Remdesivir) for hospital cases

The US Food and Drug Administration (FDA) on Friday approved the first drug to treat COVID-19 - Veklury (Remdesivir) - an antiviral medicine given through an IV for patients requiring hospitalization.

Veklury (Remdesivir) can be administered to adult and pediatric patients who are 12 years old or above and weigh at least 40 kilograms. Veklury should only be given in a hospital or in a healthcare setting which is capable of providing acute care to patients. Veklury is the first treatment for COVID-19 to receive approval from the FDA. 

This approval does not include the entire population that had been previously covered under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population, the FDA has authorized its use for treating suspected or laboratory-confirmed COVID-19 in hospitalized patients weighing between 3.5 kg to less than 40 kg. Clinical trials are still assessing the safety and effectiveness of Remdesivir in this pediatric patient population.

READ | Covaxin, Bharat Biotech's COVID Vaccine, Gets DCGI Approval For Phase 3 Of Clinical Trials

“Today’s approval is supported by data from multiple clinical trials that the FDA has rigorously assessed and represents an important scientific milestone in the COVID-19 pandemic. As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks,” said FDA Commissioner Stephen M. Hahn, M.D. 

Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use. Before approving a drug, the FDA conducts a benefit-risk assessment based on stringent scientific standards to ensure that the product’s benefits exceed its risks for the intended population. 

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

READ | Covid Cure? Trump Wants Experimental Drug Regeneron He Used Cleared By FDA; 'bugging Them'

Usage of Remdesivir and possible side effects

Important information regarding usage of Veklury to treat COVID-19 is available in the prescribing information which includes dosing instructions, potential side effects and drug interactions. 

Possible side effects of Veklury (Remdesivir) include - increased levels of liver enzymes, which may be a sign of liver injury; and allergic reactions such as 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. 

READ | Russia’s Sputnik V Vaccine To Be Tested On 100 Indian Volunteers During Its Phase-2 Trials

About FDA

The FDA is an agency within the US Department of Health and Human Services that protect the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for use. The agency is also responsible for the safety of America's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

READ | COVID Vaccine Will Under Distributed Under Special Immunization Programme: Officials