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.

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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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