US FDA grants approval to remdesivir for COVID-19 treatment

October 25, 2020 0 By FM

The US. FDA has recently approved the antiviral drug remdesivir (Veklury) for use in adult and paediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalisation.

Remdesivir is recommended to be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. It is the first treatment for COVID-19 to receive FDA approval.

The FDA revised the Emergency Use Authorization (EUA) for remdesivir authorising it to be used for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalised paediatric patients weighing 3.5 kg to less than 40 kg. Clinical trials assessing the safety and efficacy of remdesivir in this paediatric patient population are ongoing.

The approval of remdesivir was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalised with mild-to-severe COVID-19.

Possible side effects of the drug may 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, mentioned the agency.

The FDA also granted approval and reissued the revised EUA to Gilead Sciences Inc.