Silver bullet treatment is fast-tracked for trials hereAn experimental Ebola medicine will be fast-tracked through clinical trials in Korea after a coronavirus patient in the United States started to recover just a day after taking it.
If the testing timeline for the antiviral is the same as the schedule being established in China, the drug could be available in Korea within weeks.
The possible silver bullet is remdesivir, which was developed by Foster City, California-based Gilead Sciences. Gilead is perhaps best known for developing and marketing a highly effective treatment for hepatitis C.
The Korean unit of the U.S. company said Wednesday that it is in discussions with the Ministry of Food and Drug Safety to start Phase 3 clinical trials for using the drug for treating the coronavirus.
Remdesivir has so far received no approvals for the treatment of any disease. But the New England Journal of Medicine reported that first patient in the United States with the new coronavirus started to get better in just a day after given the treatment.
According to the article, all symptoms of the coronavirus in the patient vanished within days, except for a cough.
Recognizing the potential, China has already started clinical trials for remdesivir in its own country. It provided an exemption for Gilead Sciences to skip Phase 1 and 2 clinical trials and immediately jump to the final clinical trial so the experimental drug can be made available as soon as possible if it works.
China’s Ministry of Science and Technology said last week that double-blind trials of remdesivir started early this month at 10 hospitals in Wuhan, China, which is where the virus outbreak started.
The Chinese government is preparing to announce the results of the trial on April 27, a little more than two months since testing began.
To maintain a pace that impressive in Korea, Gilead Sciences Korea said it will need the same sort of advantages being offered by China.
The Ministry of Food and Drug Safety said Wednesday that it will prioritize clinical trials requests for remdesivir ahead of anything else to ensure the drug is given to patients in Korea as soon as possible.
It is expected that the health authorities will be able to safely say whether remdesivir is safe and effective in a large population within the next couple of months.
According to ClinicalTrials.gov, a database for the U.S. National Institutes of Health and National Library of Medicine, three clinical trials are currently being conducted on the drug, in Wuhan, Beijing and Omaha.
Gilead Sciences Korea said the company does not have mass-manufacturing facilities for the experimental antiviral drug at the moment but would consider expanding manufacturing operations for remdesivir if demand exists.
Some Korean coronavirus patients were treated with Kaletra, an antiretroviral therapy for H.I.V., and hydroxychloroquine, a malaria medication, but as the number of infections skyrocket and deaths surge, new and better treatments are being sought.
In response to the growing number of infections, the Ministry of Food and Drug Safety is also considering a regulatory exemption for the import of Avigan, a drug made by Tokyo’s Toyama Chemical and approved for treatment of influenza in 2014. Japanese media reported the drug proved effective in treating mild coronavirus cases. The Japanese government will be supplying the drug domestically.
BY KO JUN-TAE [firstname.lastname@example.org]
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