RIP Remdesivir
Jonathan Sackner-Bernstein, MD
Transforming Parkinson’s Disease Treatment. Track Record as Innovator. Experience at FDA and DARPA. "Worthy 100" (2023).
JAMA reported the results of a multi-center, randomized clinical trial of remdesivir for COVID-19. It failed.
Compared to placebo, a 5-day course gave a hint of advantage - though certainly not as a compelling story. More disappointing was that a 10-day course was worse than a 5-day course. When more is worse that's bad news. If more were the same then one could conclude each dose had achieved maximum benefit without causing any other adverse effects. Unfortunately, the remdesivir data don't provide any such reassurance.
Cardiology provides lessons about such dose-related phenomena.
Nesiritide's initial trials showed that a little was good for decompensated heart failure and more was worse. Eventually we learned that nesiritide had no meaningful effect and was withdrawn from the market.
Endothelin antagonism showed that a little was good and more was bad. This whole class of drugs failed during development for heart failure.
And now. unfortunately, we just learned that remdesivir is not worth the earlier excitement or commitment to clinical use.
This is not to be interpreted as any criticism of the FDA process to allow this drug to get to the market under the EUA mechanism. The data to date supported that decision, and in fact, we are learning the drug is not clearly distinguishable from placebo - not that it is dangerous. So I hope the FDA continues to use the EUA to allow promising treatments and diagnostics to get to the market.
However, these data tell me, RIP Remdesivir.