其 他 安 全 警 示
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| European Union: Review of thalassaemia medicine Zynteglo started (English only) |
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European Medicines Agency (EMA) announces that EMA’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) has begun a safety review of the medicine Zynteglo, a gene therapy authorised to treat the rare blood condition beta thalassaemia.
The review follows a case of acute myeloid leukaemia, a cancer of the blood, in a patient treated with a related investigational medicine, bb1111. This medicine uses the same modified virus (known as a viral vector) as Zynteglo, to deliver a gene into body cells.
So far, no cases of leukaemia have been reported with Zynteglo itself. The company responsible for developing both medicines has paused supply of Zynteglo while the evidence is examined.
PRAC will now examine the evidence thoroughly at EU level, working closely with experts from EMA’s Committee for Advanced Therapies (CAT), which is responsible for assessing this type of medicine, and decide on any relevant regulatory action for Zynteglo.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-march-2021
In Hong Kong, the above product is not a registered pharmaceutical product
Ends/ Saturday, 13 Mar, 2021
Issued at HKT 13:00
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