Bluebird Bio Says FDA Accepts BLA For Lovotibeglogene Autotemcel For Priority Review
(RTTNews) - bluebird bio, Inc. (BLUE) announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of December 20, 2023.
Lovo-cel is a potentially transformative one-time gene therapy for individuals living with sickle cell disease (SCD) ages 12 and older who have a history of vaso-occlusive events (VOEs).
The BLA for lovo-cel is based on efficacy results from 36 patients in the HGB-206 study Group C cohort with a median 32 months of follow-up and two patients in the HGB-210 study with 18 months of follow-up each.
The BLA submission also includes safety data from 50 patients treated across the entire lovo-cel program, including six patients with six or more years of follow-up, which is the longest follow-up of any gene therapy program for SCD.
If approved, lovo-cel will be bluebird bio's third ex-vivo gene therapy approved by the FDA for a rare genetic disease and its second FDA approval for an inherited hemoglobin disorder, building on more than a decade of leadership in gene therapy.
Bluebird Bio Q3 Loss Narrows, Tops Estimates; Revenues Miss Estimates
Sensex, Nifty Set To Open Lower As New U.S. Tariffs Take Effect
Swiss Market Settles Modestly Higher
Japanese Market Notably Higher
Thai Bourse May Halt Losing Streak On Thursday
Australian Market Slightly Lower
Indonesia Shares Tipped To Open In The Green
