Casgevy has been given 'conditional authorisation'. This means that that the company will have to provide additional evidence after authorisation. Overview · Product information · Authorisation details

13 февр. 2024 г. · CASGEVY is approved for the treatment of patients who are 12 years of age and older with severe sickle cell disease (SCD) characterized by recurrent vaso- ...

15 дек. 2023 г. · Casgevy was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to ...

This medicinal product has been authorised under a so-called 'conditional approval' scheme. This means that further evidence on this medicinal product is ...

10 мая 2024 г. · Casgevy was deemed eligible for the EMA's PRIority MEdicines (PRIME) scheme in 2020 for treating sickle cell disease. PRIME offers medicine ...

CASGEVY is the only genetic therapy approved for SCD and TDT patients in the European Union (EU) and with this approval, there are now more than 8,000 ...

13 февр. 2024 г. · The European Commission's decision follows the positive opinion adopted by the European Medicine Agency (EMA) in December 2023. A condition ...

15 дек. 2023 г. · A European Medicines Agency committee has endorsed Vertex and CRISPR Therapeutics' Casgevy for sickle cell disease and transfusion‐dependent beta thalassemia.

26 февр. 2024 г. · On February 13th 2024, the European Commission granted authorization to CASGEVY – the first CRISPR/Cas9-based gene therapy produced by ...

18 дек. 2023 г. · Following US and UK approvals, the EMA's CHMP has recommended conditional approval for Casgevy, with a decision expected in Q1 2024.