Update: 30 September 2023
- The Institute for Clinical and Economic Review (ICER) determined that lovo-cel will be cost-effective if priced between $1.35M to $2.05M. ICER has made recommendations to encourage companies to set prices toward lower end of this range to facilitate access and affordability across all insurance systems (in the USA).
- The FDA will not hold an advisory committee to discuss lovo-cel before making a decision (expected for 20 December 2023).
Update: 30 June 2023
- BLA application submitted to FDA (24 April 2023) for lovo-cel for patients with SCD who are 12 years and older and have a history of VOCs. The submission is based on the results of 36 patients in HGB-206 Group C clinical trial (median 32 months follow-up) and 2 patients in the HGB-210 study (18 months followup).
- Commercial launch is anticipated in early 2024 if approved.
- FDA has accepted Priority Review for BLA submission and set a PDUFA (the date by which the FDA must respond to the application) target date of 20 December 2023.
Sources: bluebird bio Reports First Quarter 2023 Financial Results and Highlights Operational Progress – bluebird bio, Inc.
Update: 31 March 2023
- Lovo-cel is the most deeply studied gene therapy in development for sickle cell disease, with more than 50 patients treated and multiple patients followed for more than six years.
- On track to submit biologics license application (BLA) to the U.S. Food and Drug Administration in Q1 2023.
- If approved by FDA, anticipated commercial launch in early 2024.