U.S. FDA lifts hold on Bluebird's sickle cell disease therapy

By tedtitus2808 Jun 8, 2024

Dec. 19 ( Reuters )- Blue Bank Accounnt- workvcc.com Bio Inc. announced on Monday that the U.S. health regulator had lifted a limited medical keep on studies for its gene therapy to treat sickle cell disease.


Following one patient’s case of persistent anaemia, the U.S. Food and Drug Administration’s choice puts an end to a year-long halt on future research and a halt in enrollment for continued lovo-cel studies.

After the controller has held a number of clinical trials in the past few years, the shift also signals a more positive regulatory environment for mobile and gene therapies, according to SVB Securities analyst Mani Foroohar.

According to Bluebird, its investigation revealed that those who had severe anaemia possessed a genetic predisposition known as the alpha-thalassemia trait. These individuals may be kept from upcoming drug studies.

Sickle cell disease causes a shortage of good blood cells because it takes the form of a spear rather than a round red blood cell, which can lead to complications like infection, severe chest syndrome, and stroke.

As a possible one-time care for the problem, which is thought to affect 100 000 people in the United States, Bluebird is developing the medicine.

The treatment works by incorporating a protein into a victim’s blood stem cells that may enable the body to produce anti-sickling blood.

The business, which raised concerns about going public earlier this year, is working to begin admission and care for patients between the ages of 2 and 17 ( Reporting by Aditya Samal in Bengaluru, edited by Krishna Chandra Eluri and Shailesh Kuber )

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