EMA reviews repurposed experimental cancer drug for Covid-19, even without submission – Endpoints News

In a rare move for any regulator, the European Medicines Agency said on Wednesday it had started reviewing data on the use of an experimental cancer drug to treat Covid-19, even though the Miami-based sponsor, Veru, did not submit an application.

The EMA’s review by its emergency task force follows the release of study results earlier this month showing the drug, known as sabizabulin, reduced the risk of death by 55 % in a study of 134 volunteers hospitalized with Covid-19 who received sabizabulin and 70 who received a placebo. But experts have been cautious about overinterpreting the results, which were published in the NEJM, especially since there have been very few effective treatments for people hospitalized with Covid.

Yet the trial showed that after 60 days, 45.1% of people in the placebo group died, compared to just 20.2% of those who received the new drug, equivalent to a relative reduction of 55, 2% risk of death. The independent data monitoring board unanimously stopped the study for overwhelming efficacy and safety.

Michael Steiner

Sabizabulin works by disrupting microtubules, which are part of the internal skeleton of cells, according to the EMA, and which play a role in helping SARS-CoV-2 move in and out of cells. By binding to parts of the microtubules, sabizabulin is expected to interfere with the life cycle of the virus and limit its replication and spread.

The drug Veru, which is also under review in the US – for an EUA – and the UK, is the first to be triggered under Article 18 of the new EU regulation which expanded the agency’s role in public health emergencies.

Veru shares are up more than 170% in the past six months.

Mitchell Steiner, Chairman, President and CEO of Veru, said in a statement Wednesday:

COVID-19 infections are rising sharply in Europe. Unfortunately, the mortality rate among hospitalized patients with moderate to severe COVID-19 who are at risk for ARDS remains unacceptably high with the current standard of care. By reducing the number of deaths in hospitalized patients with COVID-19, sabizabulin has great potential to play a vital role in the fight against COVID-19 in the EU. We are excited about this development at EMA by the Emergency Task Force. We were just informed yesterday that sabizabulin triggers article 18.

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