Bluebird submits sickle cell gene therapy for FDA approval, following Vertex and CRISPR Therapeutics.

Bluebird bio has submitted an application for its sickle cell gene therapy, lovo-cel, to the FDA for potential approval in patients with sickle cell disease who are 12 or older and have experienced serious attacks associated with the disease. In clinical trials, 28 of 29 patients who received the therapy had no severe attacks in the two years of the study compared to an average of 3.5 events in the two years prior to enrolling in the study. This submission sets up a race with Vertex and CRISPR Therapeutics, who have also submitted their own sickle cell therapy application to the agency.