(Reuters) – Bluebird bio Inc said on Monday it has submitted a marketing application to the U.S. Food and Drug Administration for its gene therapy to treat sickle cell disease.
The announcement comes nearly a month after the company said it would miss its goal to submit the application by the end of March for regulatory approval of lovo-cel, its gene therapy.
Bluebird said on Monday its application to the health regulator included a request for priority review, which if granted would reduce the review period to six months from the standard ten months.
The company is seeking approval for use of its therapy as a treatment for patients aged 12 and older, who are suffering from sickle cell disease, and who have a history of painful complications associated with the disease.
The gene therapy is being developed as a potential one-time treatment for the disorder, which leads to a shortage of healthy blood cells due to some of them being sickle shaped and restricting circulation in blood vessels.
Bluebird’s shares nearly 6% to $3.63 in premarket trading.
(Reporting by Bhanvi Satija in Bengaluru; Editing by Devika Syamnath and Shounak Dasgupta)
