To halve the death rate from COVID-19

PO Tx for the first severe patient. it was developed as an anti-cancer drug

Developer Veru applied for EUA from the FDA last month

Commercialization Forecast for August

Veru homepage

As the domestic quarantine authorities announced their plan to review and promote the purchase of Sabizabulin, a new oral treatment for severe patients in preparation for the COVID-19 re-pandemic, attention is being paid to the treatment.

 

Sabizabulin, developed by U.S.

 

pharmaceutical company Veru, is the first serious oral treatment for COVID-19, and is known to significantly reduce the relative risk of death compared to placebo to 55%.

 

On the 17th, the Ministry of Health and Welfare and the Korea Centers for Disease Control and Prevention reaffirmed to the National Assembly the need to introduce new oral drugs such as Paxlovid (Pfizer) and Largevrio (MSD).

 

Sabizabulin is still a candidate drug for oral severe COVID-19.

 

Developer Veru submitted an application for emergency use approval for Sabizabulin to the U.S.

 

Food and Drug Administration (FDA) early last month.

 

Developers are expected to be commercialized from August.

 

Paxlovid and Lagevrio are for mild COVID patients.

 

The difference is that the two oral drugs can be effective only when taken immediately after confirmation, while Sabizabulin has shown efficacy when used in severe patients who have already deteriorated due to confirmation.

 

Sabizabulin is known to reduce the mortality rate by half (55%) when taken, and is evaluated as a new weapon to fight the COVID-19 pandemic.

 

According to the results of a phase 3 clinical study published in the international journal New England Journal of Medicine (NEJM), Sabizabulin and standard treatments were administered to 150 severe COVID-19 patients, and the standard treatment group died 45.1% after 60 days, compared to 20.2% in Sabizabulin.

 

As a result, the relative risk of death of Sabizabulin compared to placebo was significantly reduced to 55.2%.

 

In addition, the period of hospitalization in the intensive care unit and the period of use of the ventilator were reduced by 14 days, respectively, compared to the placebo group.

 

Sabizabulin was originally developed as an anticancer drug.

 

Cancer cells grow on microtubules that move between cells in the body, blocking them from growing.

 

Researchers at the University of Tennessee in the U.S., who developed the drug in the early days of the study, began further research, believing that when the coronavirus outbreak broke out in 2020, they could block the microtubule in cells to suppress the growth of the coronavirus.

 

In the case of existing antibody treatments, the treatment effect may decrease depending on the virus mutation, but Sabizabulin is known to have no difference in the treatment effect due to the mutation.

 

This is because it acts in a way that directly interferes with the microtubule in cells necessary for virus proliferation, not the virus itself.

 

Developer Veru said, "If FDA approval is completed in July, we will be able to supply 57,000 people in July and 100,000 people in August." Veru introduces itself as a bio-cancer drug pharmaceutical company targeting bladder cancer and breast cancer.