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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