Drugs / Abicipar pegol
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn perifoveal exudative vascular anomalous complex 2 milestones | |||||
| Withdrawn | EU (EMA) | — | perifoveal exudative vascular anomalous complex | 2020-07-31 | “AbbVie also withdrew its regulatory application with the EMA for abicipar in nAMD.” abbvie.com ↗ |
| Rejected (CRL) | US (FDA) | — | perifoveal exudative vascular anomalous complex | 2020-06-26 | “has issued a Complete Response Letter to the Biologics License Application (BLA) for Abicipar pegol” abbvie.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | Japan (PMDA) | — | — | 2020-05-07 | “Abicipar: Additional filing in Japan” molecularpartners.com ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03335852 | Nov 2017 → Oct 2018 | macular degeneration | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT02859766 | Dec 2016 → Oct 2017 | macular degeneration | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT01086761 | Mar → Nov 2010 | wet macular degeneration | Allergan | Terminated | No outcome recorded |
| Phase 1 | NCT01042678 | Feb → Dec 2010 | diabetic macular edema | Allergan | Terminated | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT03539549 | May 2018 → Feb 2019 | macular degeneration | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT02181504 | Sep 2014 → Dec 2015 | macular degeneration | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT02181517 | Jul 2014 → Mar 2015 | age-related macular degeneration | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT02186119 | Jul 2014 → Jun 2015 | macular retinal edema | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT01397409 | Sep 2011 → Mar 2014 | age-related macular degeneration | Allergan | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT02462486 | Jun 2015 → Apr 2018 | macular degeneration | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT02462928 | Jun 2015 → Apr 2018 | macular degeneration | Allergan | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2020-07-20 | Molecular Partners AG | Regulatory Molecular Partners Provides Regulatory Update of European and Japanese Filings of Abicipar Pegol molecularpartners.com ↗
today announced that Allergan, an AbbVie company, has informed Molecular Partners of their intent to withdraw application filings with both the European Medicines Agency (EMA) and the Japanese Regulatory Agency (PMDA) for abicipar pegol |
| 2020-06-26 | AbbVie | Regulatory Allergan, an AbbVie Company, and Molecular Partners Receive Complete Response Letter from FDA on Biologics License Application for Abicipar pegol abbvie.com ↗
The letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration (AMD). |
| 2020-06-26 | Molecular Partners AG | Regulatory Allergan, an AbbVie Company, and Molecular Partners Receive Complete Response Letter from FDA on Biologics License Application for Abicipar pegol molecularpartners.com ↗ |
| 2019-10-31 | Molecular Partners AG | Results INTERIM MANAGEMENT STATEMENT – Q3 2019: Encouraging Additional Phase 3 Data Presented for Abicipar, and Start of Phase 1 Trial for MP0310, the First Immuno-oncology DARPin® with a Novel Therapeutic Design molecularpartners.com ↗
In the second year of these studies, quarterly-dosed of abicipar resulted in the maintenance of visual gains comparable to monthly-dosed ranibizumab (Lucentis®). |
| 2019-09-09 | AbbVie | Regulatory Allergan and Molecular Partners Announce Acceptance of U.S. FDA Biologics License Application and Validation of EMA Marketing Authorisation for Abicipar pegol in Patients with Neovascular (Wet) Age-related Macular Degeneration abbvie.com ↗
the U.S. Food and Drug Administration ( FDA ) has accepted a Biologics License Application (BLA) and the European Medicines Agency (EMA) has validated a Marketing Authorisation Application (MAA) |
| 2019-09-09 | Molecular Partners AG | Regulatory Allergan and Molecular Partners Announce Acceptance of U.S. FDA Biologics License Application and Validation of EMA Marketing Authorisation for Abicipar pegol in Patients with Neovascular (Wet) Age-related Macular Degeneration molecularpartners.com ↗
the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and the European Medicines Agency (EMA) has validated a Marketing Authorisation Application (MAA) for Abicipar pegol |
| 2018-07-19 | AbbVie | Results Allergan and Molecular Partners Announce Two Positive Phase 3 Clinical Trials for Abicipar pegol 8 and 12-week Regimens for the Treatment in Patients with Neovascular Age-Related Macular Degeneration abbvie.com ↗
In both studies abicipar demonstrated similar efficacy after 6 or 8 injections, compared to 13 ranibizumab injections in the first year of this study. |
All press releases naming this drug 13 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Abicipar Pegol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02462928 ↗ |
| Known as | AGN-150998 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01397409 ↗ |
| Known as | MP-0260 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297684 ↗ |
| Known as | MP0112 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01042678 ↗ |
| Known as | P7FHD7AG35 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297684 ↗ |
| Known as | Vegf-a binding darpin | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297684 ↗ |
| Action | Inhibit | “a novel, potentially long acting VEGF inhibitor” NCT01042678 ↗ |
| Modality | Protein / enzyme biologic | “MP0112, a designed ankyrin repeat protein (DARPin)” PMID 24907435 ↗ Jun 2014 |
| Route | Intravitreal | “Single intravitreal injection of MP0112 in the study eye” NCT01042678 ↗ |
| Target | VEGFA | “MP0112, a designed ankyrin repeat protein (DARPin) that binds with high affinity to vascular endothelial growth factor-A (VEGF-A)” PMID 24907435 ↗ Jun 2014 |