“the F.D.A.’s decision to grant the drug full approval — which means the company can now begin broadly marketing it to doctors and patients — has puzzled several outside experts, who say that it may not deserve the agency’s stamp of approval because it is, at best, a mediocre treatment for Covid-19 [remdesivir..].
“I think most people think that because a drug is F.D.A. approved, that means it must work,” said Dr. Aaron S. Kesselheim, a professor of medicine at Harvard Medical School who studies the drug industry. He and other researchers recently found that less than one-third of new drugs approved by the F.D.A. and its European counterpart over the past decade were rated as having a “high therapeutic value” by outside experts.
[..] the Institute for Clinical and Economic Review, said Gilead had made a “responsible pricing decision” that was in line with its own determination that $2,800 would be a fair price. However, that praise came with a significant caveat — the price would be fair only if remdesivir ultimately showed that it significantly lowered death rates, a benefit that has not been proven.
[..] Public Citizen, a consumer group, has estimated that the federal government has invested $70 million in remdesivir, and it sponsored the major trial that led to F.D.A. approval — and the only major study that compared it with a placebo.
[..] The F.D.A.’s approval was surprising to some because it came just days after the release of results from the Solidarity trial, a large, global study of more than 11,000 people that found that remdesivir did not reduce deaths.
Both the F.D.A. and Gilead have noted, however, that the Solidarity trial had shortcomings, including that it was not compared with a placebo, as the trial sponsored by the National Institutes of Health was.
[..] Veklury’s [brand name for remdesivir] future sales are uncertain. On the call with investors, executives said that predicting revenues in the middle of a pandemic is difficult. Around 40 to 50 percent of hospitalized Covid-19 patients receive the drug — fewer than some industry analysts had expected. But the drug is profitable so far. One Wall Street analyst, Geoffrey Porges of SVB Leerink, said Thursday that the company’s gross margin on sales to the government — the amount it pockets after the cost to produce it — appeared to be about 90 percent.
Dr. Bach [Peter B. Bach, the director of the Center for Health Policy and Outcomes] of Memorial Sloan Kettering, said that as doctors’ knowledge of Covid-19 had evolved, the significance of remdesivir had receded in favor of other options, including dexamethasone, a steroid made by several generic drug companies.”
Full article, Thomas K. New York Times, 2020.10.29