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Synonyms: Ajovy® | fremanezumab-vfrm | LBR-101 | PF-04427429 | PF-4427429 | RI-307 | RN-307 | RN307 | TEV-48125
fremanezumab is an approved drug (FDA (2018), EMA (2019))
Compound class:
Antibody
Comment: Fremanezumab (TEV-48125) is a humanised IgG2a monoclonal antibody targeting calcitonin gene-related peptide (CGRP) [3,5], a peptide known to play a role in causing migraines. TEV-48125 was originally formulated as an intravenous agent, but has been re-formulated to allow sub-cutaneous administration. Anti-CGRP antibodies are being developed as an alternative to CGRP receptor antagonists (such as telcagepant) which have already been shown to effectively reduce migraine headache and inhibit neurogenic vasodilatation in humans, and validated the CGRP/CGPR pathway as a target for the acute and preventive treatments of migraine [4]. Anti-CGRP antibodies have the advantage of longer half-lives compared to small molecule antagonists and are expected to exhibit fewer toxicities attributed to off-target interactions, toxitities which have thwarted the development of CGRP receptor antagonists.
The original patent claiming anti-CGRP antibodies held by Rinat Neuroscience Corp. who originally developed TEV-48125 (as RN307) is WO2007054809 [6]. Fremanezumab is the second CGRP/CGPR pathway targeting agent to receive marketing authorisation, following approval of the anti-CGPR monoclonal erenumab earlier in 2018. |
| No information available. |
Summary of Clinical Use  |
| TEV-48125 was evaluated as monotherapy in Phase 3 clinical trials (NCT02621931, NCT02629861, NCT02638103) for the prevention of episodic and chronic migraine. Phase 2b results are reported in [2] (chronic migraine) and [1] (episodic migraine). Full FDA approval for use as a migraine preventative was granted in September 2018, and EMA approval followed in April 2019. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT02621931 | Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine | Phase 3 Interventional | Teva Pharmaceutical Industries | ||
| NCT02629861 | Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine | Phase 3 Interventional | Teva Pharmaceutical Industries | ||
| NCT02638103 | Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine | Phase 3 Interventional | Teva Pharmaceutical Industries | ||
| External links |
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For extended ADME data see the following: Drugs.com |
