Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 14 |
| INN | Eptinezumab |
| Status | Approved |
| Drug code(s) | ALD403 |
| Brand name | VYEPTI |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Rabbit B cell derived |
| Target(s) | CGRP |
| Indications of clinical studies | Migraine prevention |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Approved EU, US, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | April 15, 2012 |
| Start of Phase 2 | March 15, 2013 |
| Start of Phase 3 | November 15, 2016 |
| Date BLA/NDA submitted to FDA | February 21, 2019 |
| Year of first approval (global) | 2020 |
| Date of first US approval | February 21, 2020 |
| INN, US product name | Eptinezumab, eptinezumab-jjmr |
| US or EU approved indications | Preventive treatment of migraine in adults |
| Company | Lundbeck |
| Licensee/Partner | None |
| Comments about company or candidate | January 24, 2022 I H. Lundbeck A/S (Lundbeck) announced that the European Commission has granted marketing authorization for Vyepti® (eptinezumab) in the European Union (EU) for the prophylactic treatment of migraine in adults who have at least four migraine days per month. Launch anticipated in Q1 2020. Oct 2019: Lundbeck has completed its takeover of US drug developer Alder BioPharmaceuticals. Feb. 22, 2019: Alder BioPharmaceuticals, Inc. today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for eptinezumab. Eptinezumab is an investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide (CGRP) and is Alder’s lead commercial candidate. If the BLA submission is accepted and the FDA grants approval of eptinezumab, Alder will be on track for a Q1 2020 commercial launch. Lundbeck acquired Alder Biopharmaceuticals, Inc. in 2019. Jan 2018: Teva Pharmaceutical Industries Ltd. granted the company rights to IP related to eptinezumab (IV ALD403). Alder also announced that the migraine prevention candidate met the primary endpoint in a second Phase III trial. Planned timing for the submission of the Company's Biologics License Application (BLA) to the FDA remains the second half of 2018. NCT01579383 Phase 1 started in April 2012. |
| Full address of company | Ottiliavej 9 2500 Valby Denmark Europe Denmark https://www.lundbeck.com/global/about-us |
Humanized rabbit antibody; proprietary yeast expression system. Aglycosylated; no FcgammaRII or III binding, reduced FcgammaR1 binding. Half-life = 28 days
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |