Takeda’s Adzynma (apadamtase alfa/cinaxadamtase alfa) Receives MHLW’s Approval for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP)
Shots:
- The approval was based on the results from the P-III clinical trial evaluating the safety, efficacy, tolerability & PK of Adzynma vs plasma-based therapies in patients aged ≥12yrs. incl .5 Japanese patients) with cTTP
- Moreover, the approval was also based on the results from a continuation study TAK-755-3002. In both trials, no patient experienced an acute TTP event with Adzynma (n=37) vs plasma-based therapies (n=38)
- Adzynma is a human recombinant ADAMTS13 (rADAMTS13) that is also approved by the US FDA for the prophylactic treatment of adult and pediatric patients with cTTP & has also received the US FDA’s ODD
Ref: Takeda | Image: Takeda
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
