Drugs / BAY94-9027
BAY94-9027
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 | “the submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA)” bayer.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01184820 | Oct 2010 → Oct 2011 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01580293 | Apr 2012 → Jun 2014 | hemophilia A | Bayer | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT01775618 | May 2013 → Mar 2015 | hemophilia A | Bayer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| 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. |
| 2017-09-07 | Bayer | Regulatory Bayer submits marketing authorization application for BAY94-9027 for the treatment of Hemophilia A in the EU bayer.com ↗
Bayer AG has submitted an application for marketing authorization for its long-acting site-specifically PEGylated recombinant human Factor VIII (BAY94-9027) for the treatment of Hemophilia A to the European Medicines Agency (EMA). |
| 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 6 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BAY 94-9027 | “BAY 94-9027 is a B-domain-deleted recombinant factor VIII (rFVIII) with site-specific attachment of poly(ethylene glycol) that has shown an extended half-life in animal models...” PMID 24843882 ↗ Apr 20145“PROTECT VIII kids extension study: Long-term safety and efficacy of BAY 94-9027 (damoctocog alfa pegol) in children with severe haemophilia A.” PMID 33724632 ↗ Mar 2021 “Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A” NCT01775618 ↗ “receiving damoctocog alfa pegol (BAY 94-9027; Jivi®) prophylaxis.” PMID 37113811 ↗ Apr 2023 |
| Known as | damoctocog alfa pegol | “PROTECT VIII kids extension study: Long-term safety and efficacy of BAY 94-9027 (damoctocog alfa pegol) in children with severe haemophilia A.” PMID 33724632 ↗ Mar 20211“receiving damoctocog alfa pegol (BAY 94-9027; Jivi®) prophylaxis.” PMID 37113811 ↗ Apr 2023 |
| Known as | Jivi | “receiving damoctocog alfa pegol (BAY 94-9027; Jivi®) prophylaxis.” PMID 37113811 ↗ Apr 2023 |
| Action | Restore | “how well the study drug corrects the factor VIII levels in your blood” NCT01184820 ↗ |
| Modality | Protein / enzyme biologic | “BAY 94-9027 is a B-domain-deleted recombinant factor VIII (rFVIII)” PMID 24843882 ↗ Apr 2014 |
| Route | Intravenous | “Single dose of Kogenate FS and 16 doses of BAY94-9027 given 2 times a week for 8 weeks. Both drugs to be given intravenously.” NCT01184820 ↗ |