Hyundai Bioscience is going straight to the United States FDA along with the company’s broad-spectrum antiviral drug candidate for the purpose of treating the monkeypox disease. The company has decided for submitting a request for a fast track processing to the Food and Drug Administration (FDA) of the United States for the CP-COV03, which an oral antiviral medicine used for the purpose of treating monkeypox that is originally developed as a treatment for the corona virus.
The decision of Hyundai biosciences came after the company learned from a US law company that is specialized in the biotechnologies that, the CP-COv03 might be granted a fast track processing under the Animal Rule. The Animal rule is kind of fast-track adopted by the US FDA as an alternative for conducting clinical trials.
Hyundai Bioscience is planning to submit a data related to the results of the animal studies of the drug to the US FDA as early as possible. Accordingly, the company has also decided for accelerating the speed of the current phase 2 study of the CP-COV03 drug for the novel corona virus by expanding the number of the hospitals where the clinical trials taking place in the coming week.
Oh Sang Ki, chief executive officer of Hyundai Bioscience said, the CP-COV03 drug is a universal antiviral drug along with niclosamide as the main ingredient that can fight against almost all of the types of virus. He also said, if the vaccine is approved as treatment for monkeypox by US FDA, they will be witnessing the birth of another innovative antiviral drug compared to penicillin.
