Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 151 |
| INN | Fremanezumab |
| Status | Approved |
| Drug code(s) | TEV-48125, LBR-101, PF-04427429, RN307, 7E9 |
| Brand name | Ajovy |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG2 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | CGRP |
| Indications of clinical studies | Migraine (episodic and chronic) |
| Primary therapeutic area | Neurological disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, Russia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2009 |
| Start of Phase 2 | January 15, 2014 |
| Start of Phase 3 | January 15, 2016 |
| Date BLA/NDA submitted to FDA | October 16, 2017 |
| Year of first approval (global) | 2018 |
| Date of first US approval | September 14, 2018 |
| INN, US product name | Fremanezumab, fremanezumab-vfrm |
| US or EU approved indications | Preventative treatment of migraine in adults |
| Company | Pfizer |
| Licensee/Partner | Teva, Otsuka |
| Comments about company or candidate | April 2019: Teva Pharmaceutical Industries Ltd. is discontinuing the clinical development program for use of fremanezumab in cluster headaches. A pre-specified futility analysis of a Phase III study in episodic cluster headache revealed that the study’s primary endpoint of mean change from baseline in the weekly average number of cluster headache attacks during the 4-week treatment period is unlikely to be met. Approved in the US in 2018 for migraine. Teva Pharmaceutical Industries Ltd. confirmed that the U.S. Food and Drug Administration (FDA) has extended the goal date of the Biologics License Application (BLA) for fremanezumab, an investigational therapy for the preventive treatment of migraine. The Prescription Drug User Fee Act (PDUFA) action date for fremanezumab is set for September 16, 2018. May 30, 2017: HALO Phase 3 study results positive; BLA to be filed later in 2017. Otsuka and Teva have made an agreement covering Japan for Otsuka to develop and commercialize Teva’s fremanezumab for the prevention of migraine. Through the agreement, Otsuka secures exclusive rights in Japan. Positive Phase 2 results reported in May 2015. Teva acquires Labrys in 2014. Phase 2 NCT02025556 and NCT02021773 studies started in January 2014. Data from Pfizer studies announced by Labrys in June 2013. Terminated by Pfizer at Phase 1 in May 2012; licensed to Labrys in Dec 2012. Teva announced in June that it will acquire Labrys. |
| Full address of company | 66 Hudson Boulevard East, New York, NY 10001-2192 USA North America United States of America https://www.pfizer.com/contact |
From FDA reveiw doc: Fremanezumab is a humanized monoclonal IgG2 antibody that, according to the Sponsor, is a calcitonin gene-related peptide (CGRP) binder that blocks both CGRP isoforms (α- and β) so that CGRP is blocked from binding to the CGRP receptor. According to the Sponsor, fremanezumab is specific for CGRP (and does not bind to closely related family members such as amylin, calcitonin, adrenomedullin, and intermedin). The Sponsor states that mutations introduced into the molecule limit antibody effector functions, preventing fremanezumab from stimulating antibody-dependent cell-mediated toxicity and triggering complement-mediated lysis. A330S; P331S mutations
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |