With input from Dr Monica Vasudev

1118:  FDA Approves Remdesivir as the First Drug for COVID-19 a Week after WHO trial showed no survival benefit

1. The US FDA has approved remdesivir for the treatment of hospitalized COVID-19 patients.
2. The drug limits SARS-CoV-2 replication.
3. It is indicated for hospitalized patients aged 12 years and above, weighing at least 40 kg.
4. Previously, the injectable drug was available under an emergency use authorization (EUA).
5. The agency also announced a new EUA in hospitalized kids 12 years and older weighing at least 3.5 kg but less than 40 kg, and in kids below the age of 12 years weighing at least 3.5 kg.
6. A week earlier, a major WHO trial reported no survival improvement for hospitalized patients treated with the drug, and no improvement in time to recovery.
7. The approval was based on three randomized trials, including the National Institutes of Health-led ACTT-1 trial, a phase III trial which revealed that patients with mild, moderate, and severe disease treated with up to 10 days of remdesivir recovered a median 5 days earlier than those given placebo (10 vs 15 days) and a median 7 days quicker in those requiring oxygen at baseline (11 vs 18 days). Fewer patients on oxygen at baseline went on to require mechanical ventilation or extracorporeal membrane oxygenation with remdesivir (13% vs 23%). Additionally, there was a trend toward lower day-29 mortality with the drug (11.4% vs 15.2%).
8. Other trials supporting the approval suggested that a 5-day course of remdesivir was roughly equivalent to a 10-day course, and that some clinical benefit was also seen in patients hospitalized with moderate illness.
9. The drug is contraindicated in those allergic to it or any of its components.
10. Adverse events more common with the drug compared to placebo included nausea and increased liver enzymes. FDA listed other possible side effects, including allergic reactions, low blood oxygen level, fever, shortness of breath, wheezing, swelling, rash, nausea, sweating, and shivering.

[Source: Medpage Today]

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA