Bukwang's COVID-19 treatment wins FDA approve to go ahead with second-phase clinical trials

By Lim Chang-won Posted : February 5, 2021, 16:16 Updated : February 5, 2021, 16:16

[Courtesy of Bukwang Pharm]

SEOUL -- Bukwang Pharm based in South Korea has won approval from the U.S. Food and Drug Administration to go ahead with second-phase clinical trials to check if its antiviral drug Levovir is effective and safe in treating COVID-19 patients. Levovir (clevudine) has been approved in South Korea and the Philippines as hepatitis B infection treatment.

Except for severe symptoms, 40 patients will be injected with Levovir and placebo. In South Korea, Bukwang has already recruited some 60 patients for clinical trials. It has been under development for treating COVID-19 in the moderate stage. Researchers are testing clevudine at lower doses in combination with adefovir for continued use. Adefovir is a prescription medicine used to treat chronic infections with hepatitis B virus.

Clevudine, the active ingredient of Levovir that inhibits the replication of viral genetic materials is an antiviral drug developed by Bukwang to treat hepatitis B, a vaccine-preventable liver infection. The company said earlier that Levovir showed similar results to Kaletra, a prescription medicine approved for the treatment of HIV infection. South Korean researchers have tested anti-viral drugs including ciclesonide, remdesivir and chloroquine.
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