Gilead Sciences has announced
collaboration with Chinese, US, and global health officials in order to investigate the safety and efficacy of its investigational antiviral compound remdesivir (GS-5734) against the novel coronavirus (2019-nCoV). Gilead is working with Chinese health authorities to establish a randomized, controlled clinical trial.
Remdesivir is a nucleotide analogue prodrug initially developed as a treatment for Ebola virus
and Marburg virus infection. Although remdesivir is not a licensed or approved drug anywhere in the world at present time, the treatment has shown activity against other coronaviruses such as severe acute respiratory syndrome (SARS) in animal models.
In its statement on the matter, Gilead noted that the first US case
of 2019-nCoV led to the administration of the drug for compassionate use after the Washington state patient developed pneumonia. In the Washington state 2019-nCoV case, physicians initiated treatment with intravenous remdesivir on day 7 of care based on the patient’s worsening clinical status. No adverse events were associated with the infusion.
The announcement was made by Merdad Parsey, MD, PhD, chief medical officer at Gilead Sciences. Parsey began
his tenure as chief medical officer on November 1, 2019.
Parsey detailed several agencies working with Gilead on remdesivir as a treatment for 2019-nCoV, such as the US Food and Drug Administration (FDA), the US Centers for Disease Control and Prevention (CDC), China’s Center for Disease Control and Prevention, and the World Health Organization.
In addition to the clinical trial likely to be initiated in China, Gilead will expand laboratory testing of remdesivir against 2019-nCoV samples and provide the drug to a limited number of physicians for emergency use.
“At the request of treating physicians, and with the support of local regulatory agencies, who have weighed the risks and benefits of providing an experimental drug with no data in 2019-nCoV, Gilead has provided remdesivir for use in a small number of patients with 2019-nCoV for emergency treatment in the absence of any approved treatment options,” Parsey said.
On February 4, the FDA issued
an emergency use authorization for the 2019-nCoV Real-Time RT-PCR Diagnostic Panel, another medical product which has not received official FDA approval but is being used in the coronavirus outbreak response.
This measure, allowing the use of the unapproved test at any qualified CDC lab in the country, came soon after Alex Azar, Secretary of the US Department of Health and Human Services, signed a public health emergency declaration
in response to 2019-nCoV.
“At this time, the risk to Americans remains low and we are working to keep in that way,” Azar said in a tweet
For the most recent cases in the novel coronavirus outbreak, visit the Contagion® Outbreak Monitor
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