EMA Begins Reviewing Cancer Medicine for COVID-19 Without Manufacturer’s Application

A first for the European Medicines Agency (EMA), the drug regulator is reviewing sabizabulin for treating COVID-19 even though the US-based developer, Veru, has not submitted an application.

Under new EU regulations (Reg 2022/123), the review by EMA’s Emergency Task Force will assist EU states in allowing use of the medicine before a possible authorization. The EMA will look into data involving the drug from a study on hospitalized patients which was published earlier this month.

“This new emergency regulatory pathway may allow the availability of sabizabulin to EU member states prior to sabizabulin being approved by EMA. Separately, we were also informed by CHMP yesterday that the sabizabulin product is eligible for submission of an application for a centralized marketing authorization,” said Mitchell Steiner, Veru’s CEO. 

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Phase 3 Sabizabulin on COVID-19 Study Demonstrated Promising Efficacy Results

A randomized, multicenter placebo-controlled Phase 3 clinical trial was conducted with hospitalized people with moderate to severe COVID-19 who were at high risk for acute respiratory distress syndrome (ARDS) and death. Almost half (45.1%) of those in the placebo group died compared with just 20.2% of those who received sabizabulin. The drug resulted in a 55.2% reduction in deaths.

Sabizabulin messes with microtubules which are responsible for helping SARS-CoV-2 enter and leave bodily cells. By binding to microtubules, the drug is expected to interfere with the life cycle of the virus and slow its replication and spread, reducing severity of COVID-19 and deaths.

The Emergency Task Force will conduct the review and release its recommendations to the Committee for Medicinal Products for Human Use (CHMP), which EU members can then decide on the drug’s authorization for use on COVID-19 patients.

Besides sabizabulin, Veru is working on multiple pipelines for breast and prostate cancer, including a Phase 3 ARTEST study of enobosarm in metastatic breast cancer.

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Fujie Tham