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Exagamglogene autotemcel (exa-cel)

Vertex secures European approval for CRISPR cell therapy

13 February 2024 | By Catherine Eckford (European Pharmaceutical Review)

Now conditionally approved in Europe for sickle cell disease and transfusion-dependent beta thalassemia, the CRISPR therapy offers eligible patients a functional cure.

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CHMP issues positive option for first gene-editing medicine

15 December 2023 | By Caroline Peachey (European Pharmaceutical Review)

If approved, Vertex’s Casgevy (exagamglogene autotemcel) would be the first gene-editing medicine authorised in the European Union.

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First CRISPR-based gene-editing therapy authorised

16 November 2023 | By Catherine Eckford (European Pharmaceutical Review)

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted a world-first regulatory authorisation to a medicine based on Nobel Prize-winning technology.

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EMA validates first regulatory submission for CRISPR-based medicine

25 January 2023 | By Catherine Eckford (European Pharmaceutical Review)

The first regulatory submission for a CRISPR-based therapy has been validated by the European Medicines Agency, to treat sickle cell disease and transfusion-dependent beta thalassemia.

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Recommended

Exagamglogene autotemcel (exa-cel)

Vertex secures European approval for CRISPR cell therapy

CHMP issues positive option for first gene-editing medicine

First CRISPR-based gene-editing therapy authorised

EMA validates first regulatory submission for CRISPR-based medicine