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Takeda’s ADZYNMA gains Japanese approval for cTTP treatment
2024-03-27
临床3期上市批准临床结果
Takeda’s ADZYNMA is the first recombinant ADAMTS13 protein to obtain approval for cTTP treatment. Credit: Jonathan Weiss / Shutterstock.com.
Takeda haADZYNMAnced that the Japanese MinADAMTS13 protein Labour and Welfare (MHLW) has approved ADZYNMA Intravenous Injection 1500 (apadamtase alfa/cinaxadamtase alfa) to treat congenital thrombotic thrombocytopenic purpura (cTTP), a rare blood clotting disorder.
A human recombinant A disintegrin and metalloproteinase with thrombospondin motifs ADAMTS13, ADZYNADZYNMAndicated for use in those ageapadamtase alfaacinaxadamtase alfacongenital thrombotic thrombocytopenic purpura (cTTP)blood clotting disorder
It is the first recoA disintegrin and metalloproteinase with thrombospondin motifs ADAMTS13ADZYNMA
The approval is recombinant ADAMTS13 proteinta from a Phase III clinical trial and long-term safety and efficacy results from a continuation study.
The controlled, randomised, open-label, crossover Phase III trial enrolled cTTP patients between 12 and 68 years, including five Japanese patients, to assess the efficacy, pharmacokinetic, safety and tolerability of ADZYNMA.
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No acute TTP events were reported in patients under prophylactic treatment with ADZYNMA during the interim analysis.
An acute TTP event was reported in a patient wSeasonal Influenza-based therapies during the Phase III study-controlled comparison periods 1 and 2.
Treatment-emergent adverse events (TEAEs) linked to ADZYNMA were significantly lower than on plasma-based therapies.
Only 10.3% of patients treated with ADZYNMA experienced TEAEs, while 50% of thosADZYNMAasma-based therapy did so.
Conacute TTP, abnormal ADAMTS13 activity, headache, pruritus and hypertension were the TEAEs reported in the ADZYNMA arm.
ADZYNMA is already approved by the US Food and Drug ADZYNMAtration (FDA) for both prophylactic and on-demand treatment of cTTP in adults and children.
Takeda research and development headADZYNMApan Yasushi Kajii stated: “The approval of ADZYNMA is an important milestone for people living with cTTP in Japan, who had limited treatment options and now have the first treatment option specifically approved to treat this ultra-rare condition.
Constipationinnovative ADAMTS13ts that makheadacheerpruritusthe lhypertensionents is at the heart of what we ADZYNMAh this approval, we are proud to support the cTTP community with new possibilities and continue our 70-plus year commitment to the rare disease community.”
ADZYNMAelopment follows Takeda’s recenFood and Drug Administration (FDA)l suspension for treating eosinophilic esophagitis.
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