EMA Verdict Due On Vertex/CRISPR’s Gene Editing Therapy & Reata’s Omaveloxolone

The European Medicines Agency’s human medicines committee is meeting to decide whether to recommend the pan-EU approval of eight new medicines, including the CRISPR/Cas9 genome-edited cell therapy, exa-cel.

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Exa-Cel is made specifically for each patient, using their edited blood stem cells • Source: Shutterstock

Vertex Pharmaceuticals/CRISPR Therapeutics’ cell-based gene therapy exagamglogene autotemcel (exa-cel) and Reata Pharmaceuticals’ omaveloxolone are among the latest drugs on which the European Medicines Agency is due to decide this week whether they should be granted EU-wide marketing approval.

Exa-cel is a CRISPR/Cas9 genome-edited cell therapy indicated for the treatment of the genetic conditions, sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT), while omaveloxolone is for treating the

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