FDA OKs Remdesivir, First Drug for COVID-19

The broad-based anti-viral drug Remdesivir meant for Covid-19 positive patients has become the first treatment to be approved by the US Food and Drug Administration (USFDA).

Over five drug makers here, including Dr Reddy's Laboratories, Cipla and Hetero Healthcare, have signed agreements with Gilead to make and supply generic versions of the patented drug in India as well as many low- and middle-income nations.

According to CNBC, the FDA has now authorized the use of the drug for all hospitalized Covid-19 patients at least 12 years old, making remdesivir the only drug currently approved as a therapeutic for the virus.

The FDA had granted remdesivir emergency authorization in May after a trial by the National Institutes of Health found that it modestly reduced the recovery time in hospitalized patients.

"The FDA is committed to expediting the development and availability of COVID-19 treatments during this unprecedented public health emergency", Dr. Stephen Hahn, the agency's commissioner, said in a statement.

The news comes exactly a week after a major global trial led by the World Health Organization (WHO) found no survival improvement for hospitalized COVID-19 patients treated with the drug, and no improvement in time to recovery.

Remdesivir, an antiviral medication given intravenously, is now approved for anyone hospitalized with COVID-19.

The ACTT-1 trial results are complemented by results of a pair of phase 3 open-label trials of remdesivir conducted in adult patients with severe and moderate COVID-19. Patients receiving the drug also needed less additional oxygen and were less likely to progress to severe disease compared to those receiving placebo. Clinical trials assessing the safety and efficacy of the drug in this pediatric patient population are ongoing, the FDA said.

Gilead, which has raised the possibility of bias in the "unblinded" World Health Organization study because patients and their doctors were aware of which treatments were being used, got initial data from the trial in late September, the World Health Organization has said.

Another WHO official in charge of clinical care said the agency will issue guidance on the use of remdesivir in three to four weeks. According to Gilead, the odds of improvement in clinical status with the 10-day treatment course of remdesivir versus standard of care were also favorable, trending toward but not reaching statistical significance (odds ratio 1.31; 95% CI, 0.88 to 1.95). Rates of serious AEs were numerically higher in the placebo group compared with the remdesivir group. "As part of the FDA's Coronovarus Treatment Acceleration Programme, the agency will to 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".