Summary
- Celgene announced that it had submitted its BLA to receive FDA approval for luspatercept to treat patients with two diseases that are associated with anemia.
- If luspatercept is given priority review, then FDA approval could be achieved by December of 2019; if not, it won't be reviewed until Q2 of 2020.
- A BLA submission to the FDA was due to positive results from the MEDALIST and BELIEVE studies, where both had met on their respective primary endpoints.
- Celgene anticipates that it could file a regulatory application for approval of luspatercept for the European Union by Q2 of 2019.
- Looking for a portfolio of ideas like this one? Members of Biotech Analysis Central get exclusive access to our model portfolio. Start your free trial today ยป
Celgene (CELG) and its partner Acceleron Pharma (XLRN) announced that they had submitted their BLA for their biologic luspatercept to the FDA for potential regulatory approval. The BLA to the FDA will be for two different diseases associated with anemia. In addition, a regulatory submission to the European Medicines Agency (EMA) is also set to be submitted in the coming months also. The main goal is to get luspatercept approved for the first few indications and, then, target the same patients who are at lower risk. This would greatly expand upon the possible market opportunity.
