Microangiopathic hemolytic anemia

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

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Venerdì, Maggio 31, 2024
General Health, Other Health, Health, Genetics, Pharmaceutical, Patient, Thrombotic thrombocytopenic purpura, ADAMTS13, Thrombocytopenia, TTP, Safety, European, Stroke, Marketing, European Commission, EMA, Toll, Mortality, Enzyme replacement therapy, Microangiopathic hemolytic anemia, Committee, CHMP

Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Medicines Agency’s (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.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Medicines Agency’s (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.
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for rADAMTS13 throughout the European Union (EU).
  • “With this positive opinion for recombinant ADAMTS13, we are one step closer to offering patients in the EU the first treatment specifically indicated for cTTP.
  • Data from this trial ( NCT03393975 ) were published in The New England Journal of Medicine in May 2024. rADAMTS13 is also being investigated in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP), the acquired form of TTP, in an ongoing Phase 2b trial ( NCT05714969 ).

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

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Martedì, Marzo 26, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Microangiopathic hemolytic anemia, Incidence, Headache, Patient, Thrombotic thrombocytopenic purpura, Constipation, Mortality, Head, TTP, Nausea, Toll, Heart, Safety, Itch, Thrombocytopenia, Hypertension, Pharmaceutical industry

Takeda ( TSE: 4502/NYSE:TAK ) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of ADZYNMA (apadamtase alfa /cinaxadamtase alfa) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older.1 ADZYNMA is the first and only approved recombinant ADAMTS13 protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme.

Key Points: 
  • Takeda ( TSE: 4502/NYSE:TAK ) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of ADZYNMA (apadamtase alfa /cinaxadamtase alfa) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older.1 ADZYNMA is the first and only approved recombinant ADAMTS13 protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme.
  • cTTP is an ultra-rare, chronic blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme.2 It is associated with acute events and debilitating chronic symptoms or thrombotic thrombocytopenic purpura (TTP) manifestations, which can include thrombocytopenia, microangiopathic hemolytic anemia, headache and abdominal pain.2,3,4 When left untreated, acute TTP events have a mortality rate of >90%.2,4
    “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,” said Yasushi Kajii, Head, R&D Japan Region at Takeda.
  • “Developing innovative treatments that make a difference in the lives of patients is at the heart of what we do.
  • In Period 3, the incidence of TEAEs was 2.8% (1/36) in this drug group: nausea and headache (1 subject each).6
    This approval does not result in any changes to Takeda’s consolidated forecast for the fiscal year ending March 31, 2024 (FY2023).

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 Thrombotic Thrombocytopenic Purpura (cTTP)

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Giovedì, Novembre 9, 2023
FDA, Health, Genetics, General Health, Pharmaceutical, Biotechnology, Migraine, Safety, Ohio State University, Toll, Food, Incidence, Abdominal pain, Upper respiratory tract infection, Headache, TTP, Disease, Hematology, Mortality, Internal medicine, Thrombotic thrombocytopenic purpura, Patient, Thrombocytopenia, Microangiopathic hemolytic anemia, Diarrhea, Nausea, Thrombotic microangiopathy, Dizziness, Vaccine, Pharmaceutical industry, ADAMTS13, Takeda

Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved ADZYNMA (ADAMTS13, recombinant-krhn) for the prophylactic and on-demand treatment of adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved ADZYNMA (ADAMTS13, recombinant-krhn) for the prophylactic and on-demand treatment of adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP).
  • “As we strive to help patients with limited or no treatment options, developing innovative treatments in rare diseases is an inspiring challenge and one we have taken on for 70-plus years as a leader in hematology.
  • “ADZYNMA provides patients with a treatment option that replaces their deficient ADAMTS13 enzyme and offers a favorable efficacy and safety profile and reduced administration time and volume compared to current plasma-based therapies.
  • ADZYNMA is a recombinant form of the ADAMTS13 protein.

Tune in to Bloomberg to Watch Advancements on Saturday, April 15th at 8:00 PM ET

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Lunedì, Aprile 10, 2023
MAHA, Advanced manufacturing, ANR, Deepfake, Thrombotic microangiopathy, Atmosphere, Hearing, Microangiopathic hemolytic anemia, Research, Carbon, Language, Capillary, Patient, Arteriole, Transport, NEO, TMA

JUPITER, Fla., April 10, 2023 /PRNewswire-PRWeb/ -- Advancements with Ted Danson is excited to announce the broadcast of an upcoming episode, scheduled to air on Saturday, April 15th at 8:00 pm ET.

Key Points: 
  • Viewers will learn how these microthrombi cause the widespread and varied end organ injury that can be seen in patients diagnosed with a TMA.
  • In addition, audiences will discover how improvements in real-time application technology are helping real estate buyers, agents, and developers.
  • Finally, the series will uncover how improvements in technology are promoting global unity by enabling shared cultural experiences across language barriers.
  • "We are excited to explore how technology continues to progress across several sectors today," said Sarah McBrayer, Creative Director for DMG Productions and the Advancements series.

United States Thrombotic Thrombocytopenic Purpura (TTP) Market Insight, Epidemiology and Market Forecast Report 2021-2030 - ResearchAndMarkets.com

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Giovedì, Novembre 18, 2021
Health, Pharmaceutical, Patient, Brain damage, Thrombosis, VWF, Thrombotic thrombocytopenic purpura, Von Willebrand factor, Plasma, SWOT, USD, Report, Toll roads in Texas, TTP, Takeda, Birth defect, Thrombocytopenia, Degenerative disease, Mutation, MAHA, Glucocorticoid, General practice, TPE, Protein, Epidemiology, Antibody, FDA, ADAMTS13, Heredity, Microangiopathic hemolytic anemia, Immunosuppression, Disease, Failure, Stroke, Kidney, Medical device, Vaccine, Pharmaceutical industry, Telecommunication

The "US Thrombotic Thrombocytopenic Purpura (TTP) Market Insight, Epidemiology and Market Forecast -2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "US Thrombotic Thrombocytopenic Purpura (TTP) Market Insight, Epidemiology and Market Forecast -2030" report has been added to ResearchAndMarkets.com's offering.
  • The Thrombotic Thrombocytopenic Purpura (TTP) market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted US Thrombotic Thrombocytopenic Purpura (TTP) market size from 2018 to 2030.
  • The Report also covers current Thrombotic Thrombocytopenic Purpura (TTP) treatment practice/algorithm, market drivers, market barriers, unmet medical needs, SWOT analysis to curate the best of the opportunities, and assesses the underlying potential of the market.
  • In 2020, the total market of thrombotic thrombocytopenic purpura was USD 316 million which included a market of USD 286 million occupied by acquired thrombotic thrombocytopenic purpura and USD 31 million occupied by congenital thrombotic thrombocytopenic purpura.