The Taiwan Food and Drug Administration (TFDA) granted conditional approval for the use of remdesivir in patients with severe COVID-19 disease. The maker of the drug, Gilead Sciences, will be required to implement a risk management plan that ensures the drug's safety as it is used. Last month, scientists reported remdesivir shortened the treatment times and reduced the chance of death in patients whose COVID-19 infections had reached the lower respiratory tract.

In a US trial, 1059 patients were enrolled in the remdesivir-COVID-19 clinical study: 538 assigned to remdesivir and 521 to placebo. Patients who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001).

The Kaplan-Meier estimates of mortality at 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04).

Serious adverse events were reported for 114 of the 541 patients in the remdesivir group (21.1%) and 141 of the 522 patients in the placebo group.

Once the data from the trial was released, the US granted provisional Emergency Use Authorization for remdesivir, even though the drug has never been formally approved for any disease. It did, however, complete the three phases of clinical trials for patients with Ebola, another coronavirus disease, but it was found to be less effective than other treatments.

The US defined severe disease as patients with an oxygen saturation (SpO2) ≤94% on room air or requiring supplemental oxygen, mechanical ventilation, and/or extracorporeal membrane oxygenation (ECMO). The drug was authorized for adult or pediatric patients who are admitted to a hospital and for whom use of an IV agent is clinically appropriate. Remdesivir is administered intravenously.

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Disclosure: none.