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Remdesivir, first FDA approved for corona treatment
Antiviral drugs that inhibit viral RNA synthesis.
Remdesivir is the first time it has been officially approved by the FDA as a treatment for Corona 19.
In Korea, the Ministry of Food and Drug Safety was aware of side effects that occurred during the phase 3 home clinical trial of remdesivir, which is used as a treatment for Corona on April 19, but approved the use of the treatment on April 22. of July.
However, it is also true that the World Health Organization (WHO) recently announced the results of a clinical study showing that remdesivir has little effect on the treatment of corona patients, which is also a concern about the approval of the FDA.
If so, what type of drug is remdesivir?
Remdesivir is structurally a nucleoside analog that targets viral RNA-dependent RNA polymerase (RdRp). The first form developed was GS-441524, with the addition of a phosphate group to Remdesivir GS-5734.
Gilead Sciences is developing a treatment for the Ebola virus.
The efficacy of GS-441524 was confirmed and this structure was optimized to derive remdesivir (GS-5734). Remdesivir, a prodrug, is converted to active GS-443902 through cellular metabolism in the body after intravenous injection and inhibits RNA polymerase with a structure similar to ATP.
Looking at the mechanism, the RNA-dependent RNA polymerase of the coronavirus synthesizes RNA and remdesivir inhibits this enzyme in respiratory epithelial cells, thus preventing the replication of the coronavirus.
As a result of pharmacokinetic studies studying drug absorption, distribution, in vivo changes and excretion, oral administration or intramuscular injection were not adequate, and intravenous administration showed the most rapid and consistent delivery of remdesivir to target cells. The half-life was 35.95 hours (Pharmaceutical Information Service).
Remdesivir is a drug that was originally being developed as a treatment for Ebola. It is active in filoviruses (eg, Ebola virus), paramyxoviruses (eg, RSV, nipavirus), and CoV (eg, SARS-CoV, MERS-CoV) and treats COVID-19. Upon completion of the clinical study for the study, it was officially approved (June).
Remdesivir is an antiviral agent that inhibits viral RNA synthesis, and RNA replication inhibitory activity has been confirmed in cell and animal models for SARS-CoV, MERS-CoV, and SARS-CoV-2.
As symptoms improved with compassionate use of remdesivir in the first confirmed cases in the United States, it was suggested as a candidate for COVID-19 treatment and then clinical trials were conducted. In the 53 cohort data published subsequently, common adverse reactions to remdesivir included elevated liver enzyme levels, diarrhea, and serious side effects, but reported no new safety concerns (NEJM, April 10).
Subsequently, Gilead received the new drug approval application with the results of two randomized phase 3 trials conducted with remdesivir and a randomized phase 3 placebo-controlled study conducted by the National Institute of Allergy and Infectious Diseases (NIAID). . Finally, on October 22 (local time), it was approved for the first time by the FDA.
Although the WHO clinical outcomes for remdesivir have been shown to be ineffective, this approval of remdesivir marks an important milestone in addressing treatment needs in the corona pendemic.
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