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Interrupted for 5 months!

 Last Update: 2021-08-02
 Source: Internet
 Author: User

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CompilationTom Lee

A few days ago, Bluebird said that the European Union Pharmacovigilance Risk Assessment Committee (PRAC) has determined that Zynteglo's treatment benefits outweigh the risks and decided to re-approve the drug to enter the European blood disease treatment market

The suspension of the Bluebird Zynteglo trial can be traced back to February this year, when Bluebird voluntarily stopped selling Zynteglo.

Because Zynteglo and LentiGlobin use the same BB305 viral vector, Bluebird has suspended the drug's sales due to the same safety considerations

Earlier last week, the European Medicines Agency (EMA) Safety Committee ruled that there was no evidence that the viral vector used by Zynteglo stimulated patients to produce AML cases

Since Zynteglo received conditional approval for the treatment of transfusion-dependent β-thalassemia (TDT) in 2019, the safety review has experienced a series of setbacks

After European regulators expressed the need to "tighten up" gene therapy, Bluebird delayed the launch of Zynteglo until 2020

In the United States, Zynteglo has not yet received FDA approval, but the company said it may submit an application at any time

In addition to safety issues, the price of the drug is also the focus of attention

Reference source: After 5-month hiatus, bluebird bio's Zynteglo bounces back in Europe with all-clear from safety group

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