Tracking the FDA’s meeting on Vertex, CRISPR’s sickle cell therapy

On Tuesday, a group of advisers to the Food and Drug Administration is meeting to discuss the merits of what could be the first CRISPR medicine approved by the agency: a treatment for sickle cell disease from partners Vertex Pharmaceuticals and CRISPR Therapeutics.

Documents published last week show that FDA scientists are focused on the technical aspects of how CRISPR does its DNA-editing work. They seem relatively convinced the treatment, known as exa-cel, is effective.

BioPharma Dive is tracking the daylong meeting, which is scheduled to run from 9 a.m. to 5 p.m. ET, and reporting on the discussion here. The most recent entries are listed first.