Bluebird Bio Files for FDA Approval of Gene Therapy Treatment for Sickle Cell Disease
- Bluebird Bio has submitted an application to the FDA for approval of its gene therapy to treat sickle cell disease.
- The company is seeking priority review, which could speed up the approval process.
- The therapy aims to treat sickle cell disease by delivering a correct copy of the gene into patients' cells.
- In a clinical trial, the treatment resolved pain crises for all 25 evaluated subjects.
- While the therapy shows promise, it still faces questions about potential risks and safety concerns.