FDA Approves Exagamglogene Autotemcel, First CRISPR Gene-Editing Therapy for SCD
The FDA has approved a gene-editing therapy for sickle cell disease (SCD) for the first time.
Source: ajmc.com
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First CRISPR Sickle Cell Patient 'Reborn': FDA Approval Expected
FDA soon rules if gene-editing CRISPR drug Exa-cel can be used commercially to treat sickle cell disease, opening door to many other therapies.
Source: forbes.com
Historic MHRA exa-cel win bagged, Crispr/Vertex await FDA nod
With a landmark U.K. approval in hand for Casgevy (exagamglogene autotemcel [exa-cel]) to treat sickle cell disease and transfusion-dependent beta thalassemia, Crispr Therapeutics AG and partner Vertex Therapeutics Inc. are turning their attention to the PDUFA dates set by the U.S. FDA for the treatment in both conditions.
Source: bioworld.com
Adcom: Don't sacrifice progress for perfection
Had it been asked to, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee would have voted Oct. 31 to recommend approval of Vertex Pharmaceutical Inc. and Crispr Therapeutics AG’s exagamglogene autotemcel, or exa-cel, as a one-time transformative treatment for severe sickle cell disease in individuals 12 and older.
Source: bioworld.com
Two Sickle Cell Disease Gene Therapies May Soon Be Approved By FDA
FDA will soon decide approval of exa-cel and lovo-cel for sickle cell disease. These may be one-time treatment options for SCD patients burdened by unmet needs.
Source: forbes.com