Experimental Rx Successfully Treats 2019-nCoV Infected Person
California based Gilead Sciences issued a statement announcing Washington State health officials used the unapproved antiviral drug Remdesivir to treat the 1st patient diagnosed with the novel coronavirus 2019-nCoV in the U.S.
Gilead said ‘Remdesivir is not yet licensed or approved anywhere and has not been demonstrated to be safe or effective for any use.’
‘Remdesivir has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are coronaviruses that are structurally similar to 2019-nCoV.’
Merdad Parsey, M.D., Ph.D., Gilead’s Chief Medical Officer, said in a press release issued on January 31, 2020, "Gilead is working closely with global health authorities to respond to the 2019-nCoV outbreak through the appropriate ‘experimental use of our investigational compound Remdesivir.”
‘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.’
According to the Spokesman, the 35-year-old man was admitted to Providence Regional Medical Center in Everett, Washington on January 20th. The pneumonia-like symptoms intensified on the 6th day. The patient continued to test positive for the 2019-nCoV and had fevers, leading the hospital staff to pursue the use of Remdesivir.
Remdesivir was administered once on the patient’s 7th day in the hospital, and no adverse events were reported afterward.
The patient’s condition was reported to have improved and staff discontinued supplemental oxygen by the 8th day.
“To my knowledge, this is the first reported case in the world where this drug has been used in a human application against this virus,” Dr. Jay Cook, chief medical officer at Providence Regional Medical Center, reported the Spokesman.
A clinical review paper was published in the New England Journal of Medicine on January 31, 2020, detailing this patient’s care.
‘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.
Previously, on March 29, 2019, the U.S. Food and Drug Administration (FDA) provided a regulatory agreement to support the development of Remdesivir as a potential Ebola Zaire treatment.
“Together with the FDA, the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services (DHHS), the China CDC and National Medical Product Administration (NMPA), the World Health Organization (WHO), and the U.S. National Institute of Allergies and Infectious Diseases (NIAID), and along with individual researchers and clinicians, Gilead is focused on contributing our antiviral expertise and resources to help patients and communities fighting 2019-nCoV.
‘While there are no antiviral data for Remdesivir that show activity against 2019-nCoV at this time, available data in other coronaviruses give us hope.’
‘There are also limited clinical data available from the emergency use of remdesivir in the treatment of patients with Ebola virus infection.’
Gilead is working with health authorities in China to establish a randomized, controlled trial to determine whether Remdesivir can safely and effectively be used to treat 2019-nCoV. We are also expediting appropriate laboratory testing of Remdesivir against 2019-nCoV samples.
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
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