Healio

Enzyme replacement therapy curbs bleeding events in congenital blood clotting disorder

Please provide your email address to receive an email when new articles are posted on . Mean maximum ADAMTS13 activity after recombinant ADAMTS13 exceeded 100%. Markedly fewer patients receiving ...
Business Wire

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)--Takeda (TSE: 4502/NYSE:TAK) today presented favorable interim results from a global pivotal Phase 3 randomized, controlled, open-label, crossover ...
Benzinga.com

FDA Flags Antibody Risk After Child's Death Linked To Takeda's Enzyme Replacement Therapy For Rare Blood Disorder

For reference, ADAMTS13 is a key regulator of blood clotting, preventing excessive clot formation in normal circulation. Its primary function is to cleave vWF, a large protein that helps platelets ...
Business Wire

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

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has ...
MedPage Today

Impact of Recombinant Replacement Therapy Detailed in Genetic Clotting Disorder

A recombinant replacement for the ADAMTS13 protein (Adzynma) missing in congenital thrombotic thrombocytopenic purpura (TTP) restored levels and reduced acute TTP events, according to interim trial ...
MedPage Today

FDA Probes Child Death Linked to Drug for Blood Clotting Disorder

The FDA said it has received postmarketing reports of neutralizing antibodies to ADAMTS13, including one death, in patients with congenital thrombotic thrombocytopenic purpura (cTTP) who were treated ...
The American Journal of Managed Care

Non-ADAMTS13 Parameters Could Benefit Differential Diagnosis in TTP

Including biomarkers for non-ADAMTS13 in routine clinical testing could benefit diagnosis and follow-up in patients with immune-mediated thrombotic thrombocytopenic purpura (TTP). Patients with immune ...
Nasdaq

Takeda’s ADZYNMA (ADAMTS13, recombinant-krhn) Approved by U.S. FDA as the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for the Treatment of Congenital ...

cTTP is an Ultra-rare Blood Clotting Disorder Associated with Life-Threatening Acute Events and Debilitating Chronic Symptoms Takeda Continues 70-plus Year Legacy of Driving Innovation for the Rare ...
Monthly Prescribing Reference

Patient Death Prompts FDA Probe Into Adzynma

Based on these postmarketing reports, the FDA is evaluating the need for further regulatory action. The Food and Drug Administration (FDA) is investigating the risk of developing neutralizing ...
News Medical

Study points to potential treatment for thrombotic thrombocytopenic purpura

A rare autoimmune disease creates sudden pain in the abdomen or the head, sending a patient to the emergency room with a potentially fatal condition. The pain comes from a multitude of blockages of ...
Nasdaq

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

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE: 4502/NYSE:TAK) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of ADZYNMA (apadamtase alfa ...