MolMed Pulls Zalmoxis Cell Therapy In EU

Company Withdraws Marketing Authorization After Failed Trial Results

 
• By Vibha Sharma
  
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The Italian biotech will redirect investment, initially reserved for Zalmoxis, to other activities that would better meet its business objectives.

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Zalmoxis Failed To Meet Its Primary Endpoint • Source: Shutterstock

Italian drug maker MolMed SPA has withdrawn the EU marketing authorization for its somatic cell therapy product, Zalmoxis, several months after an interim analysis on a Phase III trial of the product showed it to have no benefit on disease-free survival. The drug had been conditionally approved as an add-on therapy to support stem cell transplantation in patients with high-risk blood cancer. 

Zalmoxis was granted conditional marketing authorization in 2016 before the availability of confirmatory clinical trial data, to facilitate earlier access...

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