Will a gene editing therapy (e.g., CRISPR) for sickle cell disease receive full (not accelerated) FDA approval before the end of 2028?

Gene Therapy to Full Approval

The FDA granted accelerated approval to the first gene-editing therapy for sickle cell disease (e.g., Exa-cel / Casgevy) in late 2023 (simulated late 2025 context). **Full approval** requires long-term follow-up data (often 5 to 10 years) to confirm durable efficacy and safety. Given the extraordinary clinical benefits demonstrated by these treatments, and the FDA's incentive to convert promising accelerated approvals to full approvals, the strong 'Yes' vote reflects the high confidence that the companies will submit, and the FDA will review, the necessary long-term data for **full approval by the end of 2028**, granting a definitive curative designation to this groundbreaking therapy.