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Takeda Announces Approval of ADZYNMA® Intravenous Injection 1500 (apadamtase alfa /cinaxadamtase alfa) in Japan for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP) - Vimarsana News

Takeda Announces Approval of ADZYNMA® Intravenous Injection 1500 (apadamtase alfa /cinaxadamtase alfa) in Japan for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

CTTP is an Ultra-rare Blood Clotting Disorder Associated with Life-Threatening Acute Events and Debilitating Chronic Symptoms ADZYNMA is the First and Only Recombinant ADAMTS13 Enzyme...

Takeda Receives Positive CHMP Opinion for Recombinant ADAMTS13 rADAMTS13 in Congenital Thrombotic Thrombocytopenic Purpura cTTP - Vimarsana News

Takeda Receives Positive CHMP Opinion for Recombinant ADAMTS13 rADAMTS13 in Congenital Thrombotic Thrombocytopenic Purpura cTTP

Takeda TSE4502NYSETAK today announced that the European Medicines Agencys EMA Committee for Medicinal Products for Human Use CHMP has recommended the approval under exceptional circumstances of recombinant ADAMTS13 rADAMTS13 for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP.

Pivotal Phase 3 Data Presented at ISTH 2023 Congress Spotlight TAK755 Prophylaxis for Patients with Congenital Thrombotic Thrombocytopenic Purpura cTTP - Vimarsana News

Pivotal Phase 3 Data Presented at ISTH 2023 Congress Spotlight TAK755 Prophylaxis for Patients with Congenital Thrombotic Thrombocytopenic Purpura cTTP

Takeda TSE 4502NYSETAK today presented favorable interim results from a global pivotal Phase 3 randomized controlled openlabel crossover trial evaluating the safety and efficacy of TAK755 recombinant ADAMTS13 replacement therapy for the prophylactic treatment of congenital thrombotic thrombocytopenic purpura cTTP and pharmacokinetics PK characteristics of TAK755 as well as longterm data on TAK755 prophylaxis from a Phase 3b continuation study.

Pivotal Phase 3 Data Presented at ISTH 2023 Congress Spotlight TAK-755 Prophylaxis for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP) - Vimarsana News

Pivotal Phase 3 Data Presented at ISTH 2023 Congress Spotlight TAK-755 Prophylaxis for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 25, 2023--

Pivotal Phase 3 Data Presented at ISTH 2023 Congress Spotlight TAK-755 Prophylaxis for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP) - Vimarsana News

Pivotal Phase 3 Data Presented at ISTH 2023 Congress Spotlight TAK-755 Prophylaxis for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 25, 2023--