FDA is in Discussions with Gilead to Make Remdesivir Available As Quickly as Possible

At the rate of how many are being infected with coronavirus and how many are dying, there is a rush to get treatment to patients.

The Food and Drug Administration is now in ongoing discussions with Gilead to make their antiviral drug remdesivir available to coronavirus patients as “quickly as possible.”

The FDA announced on Wednesday that it has been in “sustained and ongoing” discussions with Gilead Sciences to make remdesivir available to Covid-19 patients “as quickly as possible, as appropriate.”

White House health advisor Dr. Anthony Fauci said on Wednesday that data from a coronavirus drug trial testing Gilead’s drug showed “quite good news” and sets a new standard of care for Covid-19 patients.

Fauci said he was told data from the trial showed a “clear-cut positive effect in diminishing time to recover.”

FDA spokesman Michael Felberbaum told CNBC, “As part of the FDA’s commitment to expediting the development and availability of potential COVID-19 treatments, the agency has been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.”

Gilead released preliminary results from its own single arm study that revealed at least 50% of the patients treated with a five-day dosage of remdesivir improved. The clinical trial involved 397 patients with severe cases of Covid-19.

“Unlike traditional drug development, we are attempting to evaluate an investigational agent alongside an evolving global pandemic. Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for COVID-19 and how to best utilize the drug,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.

“These study results complement data from the placebo-controlled study of remdesivir conducted by the National Institute for Allergy and Infectious Diseases and help to determine the optimal duration of treatment with remdesivir. The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir. This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”

Disclaimer: We have no position in Cresco Labs Inc. (NASDAQ: GILD) and have not been compensated for this article.