FDA moving at 'lightning speed' on Gilead drug, commissioner says

Friday, 01 May, 2020

Nor is it even clear there will be a market for remdesivir, long-term, if effective treatments and/or vaccines are discovered.

The company said it will share additional remdesivir data from the company's open-label Phase three SIMPLE trial in patients with severe COVID-19 disease shortly.

"The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery, " Fauci said.

Fauci said the mortality rate "trended towards being better" for patients taking remdesivir, although the preliminary data didn't show a statistically significant difference.

"It's quite good news", Fauci said regarding the NIAID study.

Dr. Vinay Malhotra, principal investigator in the Gilead trial, said MultiCare has since treated 53 patients, including some from Spokane, with the drug at MultiCare Deaconess Hospital and MultiCare Valley Hospital.

The big picture: Remdesivir could provide some help and lay the groundwork for more research, but this drug on its own does not appear to be any kind of "cure" for the novel coronavirus. "What it has proven is that a drug can block this virus". "I hope they don't do that". While it has also been granted the investigational antiviral Orphan Drug status by the FDA, it is not approved by the FDA or anywhere in the world. Being able to test remdesivir on patients when infected cases were peaking, the federal study enrolled over 800 patients, compared with the 237 patients in the Chinese trial.

The study's main goal also was altered.

Patients still need other care to support their recovery, he said, especially if the inflammation that can be associate with COVID-19 has already damaged their organs. The new main goal is time to recovery, such as no longer needing oxygen or hospitalization.

"They have not made a final decision yet, they have not announced it, but I would project that we're going to be seeing that reasonably soon".

This means "we can significantly increase the number of courses available, all of which Gilead has committed for donation", said O'Day.

"The virus is not very careful about what it incorporates", said virologist Benjamin Neuman, of Texas A&M University.

In his remarks to the press, Dr Fauci indicated that the approach could pave the way for better drugs adopting the same model.

A senior official in the Trump administration told the New York Times that the authorization could be announced as early as Wednesday, the same day that news of the hospital trial, conducted by the National Institute of Allergy and Infectious Disease (NIAID), was released. "This represents about 140,000 10-day treatments and 250,000 5-day treatments" - a significant amount of product being given away for free.

Nahid Bhadelia, who directs the special pathogens unit at Boston University School of Medicine and was not involved with the study, says she suspects remdesivir will have the most impact earlier in the course of disease. In recent years, we have been studying its impact in hemorrhagic fever viruses such as Ebola, Marburg and Nipah viruses as well as other coronaviruses such as SARS and MERS. Last month, the agency allowed for use of the malaria drugs hydroxychloroquine and chloroquine in hospitalized patients.

The full details have not been published, but experts said it would be a "fantastic result" if confirmed, but not a "magic bullet" for the disease.