Without application: EMA tests new Covid 19 drug


Without application: EMA tests new Covid 19 drug

An active ingredient from cancer research could become a new drug against severe disease progression from Covid 19: The European Medicines Agency EMA began examining existing data on sabizabulin before the manufacturer actually applied for approval. The substance showed a significant reduction in patient mortality.

Over the past two years, active pharmaceutical ingredients from “other” fields of application have been tested time and again, some with positive effects on Covid-19, and are now used as SARS-CoV-2 therapeutics. Examples include the monoclonal antibody tocilizumab (against interleukin-6; anti-IL-6) used in rheumatoid arthritis (“joint rheumatism”, chronic polyarthritis) or so-called JAK inhibitors such as baricitinib, which are also used in chronic polyarthritis .

Drug inhibits duplication
Sabizabulin is a substance developed by the American company Veru that is intended as an inhibitor of the cell structure (microtubule disruptor) to stop the division of cancer cells. The German Pharmazeutische Zeitung noted: “Like colchicine, it binds to subunits of the microtubules and cross-links them, stopping the cell cycle. This especially affects rapidly dividing cells. Microtubules also assist the SARS-CoV-2 coronavirus in entering and exiting the human host cell. Sabizabulin is therefore said to inhibit viral replication.” In addition, the inflammatory response is dampened in the context of Covid 19 disease.

Positive results, good effectiveness
Good efficacy was demonstrated in a study with sabizabulin, which was evaluated early due to statistically significant successes. In the study, published July 6 in the New England Journal Evidence, 134 critically ill Covid-19 patients who required artificial oxygen and were at high risk (high-grade obesity, serious other diseases, etc.) were treated with once a day. nine milligrams of sabizabulin in tablet form in addition to usual therapy (remdesivir, cortisone, tocilizumab, baricitinib, etc.). These were patients with SARS-CoV-2 infections of the delta or ommicron variants. 70 other subjects were given a placebo instead of sabizabulin. The Phase III clinical trial was conducted at centers in the US, Brazil and Bulgaria.

The results were clear. “The administration of sabizabulin was able to reduce the risk of a fatal course within the next 60 days by 55.2 percent compared to placebo. In the 52 subjects in the placebo group, the death rate (death from any cause) was 45.1 percent compared to 20.2 percent with the addition of sabizabulin. The length of stay in the intensive care unit was reduced by 43 percent, the number of days on mechanical ventilation by 49 percent and the length of stay in hospital by a total of 26 percent,” the Pharmazeutische Zeitung summarizes the results.

Exam without application
The EMA has started examining the already available data on the potential drug, although it has not yet received an application for approval from the manufacturer. This is the first procedure of this kind at the European Medicines Agency. This is made possible by new EU legislation resulting from the Covid-19 pandemic, which aims to speed up the potential access to new medicines.

Source: Krone


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