Drugs / KW-3357
KW-3357
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | ATryn | — | 2018-12-22 | europa.eu ↗ |
| Filed | Japan (PMDA) | — | congenital antithrombin deficiency, disseminated intravascular coagulation | 2014-08-01 | “filed an application for marketing approval to the Ministry of Health, Labour and Welfare (MHLW) for recombinant human antithrombin (AT) preparation (code name: KW-3357)” kyowakirin.com ↗ |
| Approved | EU (EMA) | ATryn | — | 2006-07-28 | europa.eu ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03090893 | Jun 2018 → Jun 2019 | hereditary antithrombin deficiency | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT01598883 | Jun 2012 → Dec 2014 | — | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT01158729 | Aug 2011 → Dec 2013 | — | Medical College of Wisconsin | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00938288 | Apr 2009 → Dec 2010 | hereditary antithrombin deficiency | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00506519 | Jul 2007 → Mar 2009 | disseminated intravascular coagulation | LEO Pharma | Terminated | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT01384409 | Feb → Oct 2012 | disseminated intravascular coagulation | Kyowa Kirin, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01384396 | Dec 2011 → Apr 2013 | disseminated intravascular coagulation | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01384903 | Jun 2011 → May 2013 | disseminated intravascular coagulation | Kyowa Kirin, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2023-09-28 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Top-Line Results of Phase 3 Clinical Study of KW-3357 for the Treatment of Preeclampsia in Japan kyowakirin.com ↗
Regarding the efficacy, there was a trend toward longer days of maintaining pregnancy in the KW-3357 group compared to the placebo group, but the difference did not reach statistical significance . |
| 2016-04-25 | Knight Therapeutics (USA) Inc | Regulatory Knight Receives NOD from Health Canada for ATryn(R) knighttx.com ↗
Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, today announced that it has received a Notice of Deficiency (“NOD”) for its ATryn ® New Drug Submission. |
| 2015-08-06 | Knight Therapeutics (USA) Inc | Regulatory Knight and LFB S.A. Announce Filing of New Drug Submission for ATryn(R) knighttx.com ↗
Knight Therapeutics Inc. (TSX:GUD) (“Knight” or the “Company”), a leading Canadian specialty pharmaceutical company, and LFB S.A., a biopharmaceutical Group focused on innovative therapeutics for serious and rare diseases, today announced that Knight’s New Drug Submission (NDS) has been accepted for review by Health Canada for ATryn® [Antithrombin (Recombinant)] for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. |
| 2015-07-03 | Kyowa Kirin, Inc. | Regulatory Approval for ACOALAN® in Japan kyowakirin.com ↗
announced today that it has received approval for thrombophilia due to congenital antithrombin (AT) deficiency (CAD) and disseminated intravascular coagulation (DIC) |
| 2014-08-01 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Submits Application for Approval in Japan for KW-3357 kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has filed an application for marketing approval to the Ministry of Health, Labour and Welfare (MHLW) for recombinant human antithrombin (AT) preparation (code name: KW-3357) which is developed for thrombophilia due to congenital AT III deficiency (CAD) and disseminated intravascular coagulation (DIC) accompanied by a decrease in AT III. |
All press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-09-28 | Kyowa Kirin, Inc. | Kyowa Kirin Announces Top-Line Results of Phase 3 Clinical Study of KW-3357 for the Treatment of Preeclampsia in Japan kyowakirin.com ↗ |
| 2019-11-20 | Kyowa Kirin, Inc. | Kyowa Kirin Initiated Phase 3 Clinical Study of KW-3357 for the Treatment of Preeclampsia kyowakirin.com ↗ |
| 2016-04-25 | Knight Therapeutics (USA) Inc | Knight Receives NOD from Health Canada for ATryn(R) knighttx.com ↗ |
| 2015-08-06 | Knight Therapeutics (USA) Inc | Knight and LFB S.A. Announce Filing of New Drug Submission for ATryn(R) knighttx.com ↗ |
| 2015-07-03 | Kyowa Kirin, Inc. | Approval for ACOALAN® in Japan kyowakirin.com ↗ |
| 2014-08-01 | Kyowa Kirin, Inc. | Kyowa Hakko Kirin Submits Application for Approval in Japan for KW-3357 kyowakirin.com ↗ |
| 2011-06-29 | Kyowa Kirin, Inc. | Kyowa Hakko Kirin announces a Commencement of Phase 3 Clinical Study for KW-3357 in Japan kyowakirin.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | KW-3357 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01384409 ↗ |
| Known as | Antithrombin (Recombinant) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01158729 ↗ |
| Known as | Antithrombin alfa | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00506519 ↗ |
| Known as | ATRYN | “Recombinant Human Antithrombin (ATryn®) in the Treatment of Patients With DIC Associated With Severe Sepsis” NCT00506519 ↗3“continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®)” NCT03090893 ↗ |
| Known as | rhAT | “continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®)” NCT03090893 ↗ |
| Action | Restore | “Antithrombin replacement therapy is often administered during these periods” NCT00938288 ↗ |
| Modality | Protein / enzyme biologic | “Recombinant Human Antithrombin (ATryn®)” NCT00506519 ↗ |
| Route | Intravenous | “continuous intravenous (IV) infusion over five days” NCT00506519 ↗ |