FDA Could Approve Remdesivir For Emergency Use As Soon As Tomorrow

FDA Could Approve Remdesivir For Emergency Use As Soon As Tomorrow

When Dr. Fauci said the FDA and Gilead would move to “quickly” get remdesivir into the hands of COVID-19 patients, we didn’t think they’d move this quickly.

In a sudden break from a federal virus response that has at times been criticized for unnecessary delays – delays drive by petty political squabbles and other hangups, from the ‘PPP’ to the CDC’s badly botched testing rollout – the FDA could move to grant emergency approval to remdesivir, an antiviral initially developed to treat ebola, but was never approved for that, or any other, medical purpose – as quickly as Wednesday aka tomorrow.

That’s according to the NYT, which spoke to a ‘senior official’ about the matter. It has all the hallmarks of an authorized ‘leak’, probably OK’d directly by Dr. Fauci himself (native New Yorker that he is).

To be sure, there remains some dispute about the drug’s efficacy, as we pointed out earlier. Despite all that, Gilead announced some positive data from a NIAD study earlier today – that the drug had met its ‘target’ of shortening recovery time – by Gilead is apparently enough to satisfy Dr. Fauci, who said remdesivir reminded him of the early data on studies of AZT during the AIDS outbreak. He explained that some of the initial studies were inconclusive, even as positive results seemed to be readily apparent.

As we mentioned earlier, Dr. Fauci said the results of the study showed that the drug could “block” the virus. And President Trump seemed happy enough to approve, defying critics who might have inspected him to push hydroxychloroquine until millions die from fish tank cleaner poisoning.

Dr. Fauci said the federal trial indicated that the drug remdesivir could shorten the time to recovery by about a third. “Although a 31 percent improvement doesn’t seem like a knockout 100 percent, it is a very important proof of concept because what it has proven is that a drug can block this virus,” Dr. Fauci said. “This is very optimistic.”

Mr. Trump called that a good sign. “Certainly it’s a positive, it’s a very positive event,” he said.

In a statement, Gilead Sciences said it was “aware of positive data emerging from” the study by Dr. Fauci’s institute, known as NIAID. “We understand that the trial has met its primary endpoint and that NIAID will provide detailed information at an upcoming briefing.”

Remdesivir is not yet licensed or approved in the United States or anywhere in the world “and has not yet been demonstrated to be safe or effective for the treatment of Covid-19,” according to Gilead.

Whether the drug can reduce the mortality rate in a more “statistically significant” way remains unclear, as does whether the drug is strictly safe for all human patients.

Tyler Durden

Wed, 04/29/2020 – 14:32

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