Takeda Reports the US FDA Acceptance of BLA and Granted Priority Review of TAK-755 for Congenital Thrombotic Thrombocytopenic Purpura
Shots:
- The US FDA has accepted the BLA & granted priority review for TAK-755 for cTTP. The BLA was based on the first P-III randomized trial in cTTP, and supported by long-term safety and efficacy data from a continuation study and supported by long-term safety & efficacy data from a continuation study
- The interim P-III results showed a 60% reduction in the incidence of thrombocytopenia events over plasma-based therapy, patients experienced AEs (8.9% vs 47.7%)
- TAK-755, the first recombinant ADAMTS13 protein received ODD in the US, EU & Japan for TTP, Rare Pediatric Disease Designation for cTTP, FTD for prophylaxis of acute episodes of TTP in patients with hereditary ADAMTS13 deficiency
Ref: takeda | Image: takeda
Related News:- Takeda Reports BLA Resubmission to the US FDA for Entyvio as a Maintenance Therapy for Ulcerative Colitis
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Tags
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
