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COVID-19: Gilead pauses compassionate use of experimental antiviral for COVID-19

2020/03/24  RAPS

Biopharma company Gilead said Sunday that it would temporarily pause allowing the use of the potential COVID-19 treatment remdesivir outside of clinical trials as the company looks to ramp up wider use of the antiviral following discussions with regulators worldwide.

Formerly a potential Ebola treatment, remdesivir is an experimental, intravenous antiviral and is in five clinical trials in the US and China to treat COVID-19. According to FDA, remdesivir has been used in about 250 patients in the US on a compassionate use basis, meaning outside of the clinical trials. Gilead also said the drug was supplied to Europe and Japan. On Monday, the antiviral received orphan drug designation from FDA because when the application was filed, COVID-19 affected fewer than 200,000 Americans.

The halt to new patients receiving the experimental treatment effectively means that only those who are in the trials will receive it for the time being, with the exception of pregnant women and those under 18 with confirmed COVID-19. Initial data from the clinical work is expected next month.

“During this transition period, we are unable to accept new individual compassionate use requests due to an overwhelming demand over the last several days,” Gilead said. “We are focused now on processing previously approved requests and anticipate the expanded access programs will initiate in a similar expected timeframe that any new requests for compassionate use would have been processed.”

The company also cited “an exponential increase” in compassionate use requests for emergency access to remdesivir that “flooded an emergency treatment access system that was set up for very limited access to investigational medicines and never intended for use in response to a pandemic.”

According to the CDC, other possible treatments for COVID-19, none of which have been approved by FDA for specifically treating the disease, include hydroxychloroquine, which is malaria treatment that has been administered to hospitalized COVID-19 patients in multiple countries, including in the US.

One small study reported that hydroxychloroquine alone or in combination with azithromycin “reduced detection of SARS-CoV-2 RNA in upper respiratory tract specimens compared with a non-randomized control group but did not assess clinical benefit,” the CDC said. But there are no currently available data from randomized controlled trials to inform clinical guidance on the use, dosing or duration of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection, the CDC added.

New York Gov. Andrew Cuomo (D) said Sunday that his state acquired 70,000 doses of hydroxychloroquine, 10,000 doses of Zithromax (azithromycin) and 750,000 doses of chloroquine to implement drug trials that will start tomorrow.

“I want to thank the FDA for moving very expeditiously to get us this supply. The President ordered the FDA to move and the FDA moved,” Cuomo said. He also said he thought FDA should start approving serologic tests for coronavirus antibodies.

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Update on March 25

Gilead Asks FDA to Rescind Orphan Designation for COVID-19 Antiviral

In a reversal, Gilead said Wednesday that it submitted a request to the US Food and Drug Administration (FDA) to rescind the orphan drug designation it was granted for the investigational antiviral remdesivir for the treatment of COVID-19.

Earlier in March, Gilead was granted the designation because the potential antiviral would help to treat COVID-19, which currently affects fewer than 200,000 patients in the US. If the company had kept the designation and remdesivir won approval, the treatment would have received seven years of orphan drug exclusivity (although the patents on remdesivir will last for longer than seven years) and tax credits for some of the research done on remdesivir. Still, criticism of the designation was widespread, especially as the number of COVID-19 cases grows.

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