Drugs / TAK-755
TAK-755
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | congenital thrombotic thrombocytopenic purpura | 2023-05-16 | “the U.S. Food and Drug Administration (FDA) has accepted Takeda’s Biologics License Application (BLA) for TAK-755” takeda.com ↗ “The TAK-755 application was accepted by the FDA on May 16th” takeda.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03997760 | Oct 2019 → Oct 2022 | sickle cell disease | Shire | Completed | No outcome recorded |
| Phase 1 | NCT02216084 | Sep 2014 → Feb 2016 | congenital thrombotic thrombocytopenic purpura | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07392450 | Apr 2026 → Dec 2027 expected | ischemic stroke | Takeda | Recruiting | No outcome recorded |
| Phase 2 | NCT05714969 | Jul 2023 → Apr 2026 | thrombotic thrombocytopenic purpura | Takeda | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT04683003 | Apr 2021 → Mar 2027 expected | congenital thrombotic thrombocytopenic purpura | Takeda | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03393975 | Oct 2017 → Dec 2023 | congenital thrombotic thrombocytopenic purpura | Baxalta now part of Shire | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05770219 | — | thrombotic thrombocytopenic purpura | Takeda | Approved for marketing | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2024-08-07 | Takeda | Regulatory Takeda Receives European Commission Approval for ADZYNMA®▼ (Recombinant ADAMTS13) as the First and Only Recombinant ADAMTS13 Replacement Therapy for Congenital Thrombotic Thrombocytopenic Purpura (cTTP) takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADZYNMA®▼ (recombinant ADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP). |
| 2024-05-31 | Takeda | Regulatory Takeda Receives Positive CHMP Opinion for Recombinant ADAMTS13 (rADAMTS13) in Congenital Thrombotic Thrombocytopenic Purpura (cTTP) takeda.com ↗
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. |
| 2024-03-26 | Takeda | Regulatory Takeda Announces Approval of ADZYNMA® Intravenous Injection 1500 (apadamtase alfa /cinaxadamtase alfa) in Japan for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP) takeda.com ↗
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. |
| 2023-11-09 | Takeda | Regulatory 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) takeda.com ↗
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). |
| 2023-06-25 | Takeda | Results Pivotal Phase 3 Data Presented at ISTH 2023 Congress Spotlight TAK-755 Prophylaxis for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP) takeda.com ↗
In the pivotal trial, no patient had an acute TTP event while receiving TAK-755 prophylactic treatment. |
| 2023-05-17 | Takeda | Regulatory U.S. Food & Drug Administration Grants Priority Review of TAK-755 for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP) takeda.com ↗
The TAK-755 application was accepted by the FDA on May 16th, and has been granted Priority Review. |
| 2023-01-05 | Takeda | Results Takeda Announces Favorable Phase 3 Safety and Efficacy Results of TAK-755 as Compared to Standard of Care in Congenital Thrombotic Thrombocytopenic Purpura (cTTP) takeda.com ↗
The interim results showed that TAK-755 reduced the incidence of thrombocytopenia events by 60% (95% Confidence Interval, 30%-70%), an important marker of disease activity in cTTP, as compared to SoC. |
| 2017-03-22 | Takeda | Regulatory Shire receives FDA Fast Track designation for recombinant ADAMTS13 (SHP655) for treatment of hereditary thrombotic thrombocytopenic purpura takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for recombinant ADAMTS13 (SHP655 - historically known as BAX930) for treatment of acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP) |
All press releases naming this drug 8 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TAK-755 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04683003 ↗ |
| Known as | BAX930 | “Safety, tolerability, and pharmacokinetics of recombinant ADAMTS-13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13; BAX 930; SHP655) were...” PMID 28912376 ↗ Sep 20171“BAX930 (rADAMTS13): A Phase 1 Prospective, Uncontrolled, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety and Pharmacokinetics in Hereditary Thrombotic...” NCT02216084 ↗ |
| Known as | rADAMTS13 | “rADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) is a lyophilized formulation for intravenous injection.” NCT02216084 ↗ |
| Known as | recombinant ADAMTS-13 | “Safety, tolerability, and pharmacokinetics of recombinant ADAMTS-13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13; BAX 930; SHP655) were...” PMID 28912376 ↗ Sep 2017 |
| Known as | SHP655 | “Safety, tolerability, and pharmacokinetics of recombinant ADAMTS-13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13; BAX 930; SHP655) were...” PMID 28912376 ↗ Sep 2017 |
| Modality | Protein / enzyme biologic | “recombinant ADAMTS-13” PMID 28912376 ↗ Sep 2017 |
| Route | Intravenous | “lyophilized formulation for intravenous injection” NCT02216084 ↗ |