Drugs / Damoctocog
Damoctocog
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | hemophilia B leyden | 2017-08-31 | “submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for its long-acting site-specifically PEGylated recombinant human Factor...” bayer.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT03364998 | Nov 2017 → Jan 2018 | hemophilia A | Bayer | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2018-11-27 | Bayer | Regulatory Bayer receives EU approval for its hemophilia A treatment Jivi® bayer.com ↗
Bayer announced today that Jivi® (BAY94-9027) has been approved by the European Commission for the treatment and prophylaxis of bleeding in previously treated patients 12 years of age or older with hemophilia A. |
| 2018-09-21 | Bayer | Regulatory Bayer’s Jivi® approved in Japan for hemophilia A bayer.com ↗
Bayer announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Jivi® (BAY94-9027) for the prophylactic treatment of hemophilia A for adults and adolescents 12 years of age or older in Japan. |
| 2018-09-21 | Bayer | Regulatory Bayer receives positive CHMP opinion for its hemophilia A treatment BAY94-9027 bayer.com ↗ |
| 2018-08-30 | Bayer | Regulatory Bayer receives US approval for modern hemophilia A treatment Jivi® with a step-wise prophylaxis dosing regimen bayer.com ↗
Bayer announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older in the U.S. |
| 2017-10-17 | Bayer | Regulatory Bayer submits its extended half-life hemophilia A compound for marketing authorization in Japan bayer.com ↗
Bayer has submitted an application for marketing authorization for its extended half-life site-specifically PEGylated recombinant human Factor VIII (BAY94-9027, damoctocog alfa pegol) for the treatment of hemophilia A in Japan. |
| 2017-08-31 | Bayer | Regulatory Bayer submits Biologics License Application in the U.S. for BAY94-9027 - a long-acting factor VIII for the treatment of Hemophilia A bayer.com ↗
Bayer AG today announced the submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for its long-acting site-specifically PEGylated recombinant human Factor VIII (BAY94-9027) for the treatment of Hemophilia A. |
All press releases naming this drug 7 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Damoctocog | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03364998 ↗ |
| Known as | BAY 94-9027 | “BAY 94-9027 is an extended-half-life, recombinant factor VIII (rFVIII) product conjugated with a 60-kDa branched polyethylene glycol (PEG) molecule indicated for use in...” PMID 31236667 ↗ Jun 20191“Damoctocog (Jivi, BAY94-9027)” NCT03364998 ↗ |
| Known as | Jivi | “Damoctocog (Jivi, BAY94-9027)” NCT03364998 ↗ |
| Modality | Protein / enzyme biologic | “BAY 94-9027 is an extended-half-life, recombinant factor VIII (rFVIII) product” PMID 31236667 ↗ Jun 2019 |
| Route | Intravenous | “after intravenous administration” NCT03364998 ↗ |