Among a total of 3,228 existing drugs, the research team examined them to find what is cell-directed and showed efficacy without causing resistance, ending up with four candidates, among which niclosamide was the only one that received FDA approval. This study was published in the international scientific journal Vaccines in July 2020. Researchers at Kansas State University in the US published a study result in which niclosamide demonstratably lowered the proliferation of vaccinia virus (VACV), a virus within the same family as the monkeypox virus, to a whopping one-hundredth level even at a concentration as low as 1 micromole. Niclosamide, the active ingredient of CP-COV03, has already been shown to have excellent efficacy against monkeypox type of virus, according to a recently published research. Hundai Bioscience plans to submit data related to results of animal studies of CP-COV03 to the FDA as swiftly as possible. There are 12 other new drugs the FDA applied the animal rule pathway for granting marketing authorization. Tpoxx is a treatment for smallpox developed with efficacy established from animal testing by Siga Technologies, a US pharmaceutical company, and the FDA approved it as a treatment for smallpox in 2018 under Animal Rule.
Animal Rule is sort of a fast-track adopted by the US FDA for new drugs (e.g., smallpox or monkeypox), as an alternative to conventional clinical trials, allowing approval of new drugs and biological products based on efficacy data obtained solely from animal testing in situations infeasible or unethical to conduct clinical testing on humans. Hyundai Bioscience's decision came after it learned, through a US law firm that specializes in biotechnologies, that CP-COV03 may be granted a fast track processing under the Animal Rule. Hyundai Bioscience, a biotechnology company that developed and commercialized bio-fusion technology with the purpose of delivering active ingredients safely and efficiently to the body, has decided to submit a request for a fast track processing to the US Food and Drug Administration (FDA) for CP-COV03, an oral antiviral medicine for the treatment of monkeypox, which it developed as a treatment for Covid-19. Hyundai Bioscience to seek fast track processing from US FDA for oral antiviral medicine, CP-COV03, to treat monkeypox You can get e-magazine links on WhatsApp.
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