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| Primary information |
|---|
| ID | 15444 |
| Therapeutic ID | Th1597 |
| Protein Name | Fremanezumab |
| Sequence | >Th1597_Fremanezumab
EVQLVESGGGLVQPGGSLRLSCAASGFTFSNYWISWVRQAPGKGLEWVAEIRSESDASATHYAEAVKGRFTISRDNAKNSLYLQMNSLRAEDTAVYYCLAYFDYGLAIQNYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTKVDKTVERKCCVECPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYKCKVSNKGLPSSIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
|
| Molecular Weight | 148000 |
| Chemical Formula | NA |
| Isoelectric Point | NA |
| Hydrophobicity | NA |
| Melting point | NA |
| Half-life | The mean half-life recorded for fremanezumab was similar across doses for Japanese and Caucasian study subjects and was estimated to be approximately 31-39 days.[A33125,L11749] |
| Description | Fremanezumab is a humanized monoclonal antibody targeted against human calcitonin gene-related peptide (CGRP) for the prevention of migraine headaches.[L11749] It was developed by Teva Pharmaceuticals USA and approved by the FDA in September 2018.[L11779] Along with other recently approved anti-CGRP therapies such as [galcanezumab], [erenumab], and the oral CGRP antagonist [ubrogepant], fremanezumab represents an important step forward in the treatment and prevention of migraine headaches. |
| Indication/Disease | Fremanezumab is indicated for the preventative treatment of migraine in adults.[L11749] |
| Pharmacodynamics | Fremanezumab is a subcutaneous injection that targets the calcitonin gene-related peptide (CGRP) ligand, preventing its binding to the CGRP receptor.[A33114,L11749] It possesses a long duration of action requiring only monthly or quarterly administration and appears well-tolerated in clinical trials.[L11749] |
| Mechanism of Action | Studies dating back to 1985 have demonstrated that CGRP levels increase during acute migraine attacks in migraine-suffering patients but normalize after administration of antimigraine therapy such as [sumatriptan].[A33090] Moreover, research has shown that intravenous administration of CGRP can induce migraine-like attacks in migraine-suffering patients.[A33090] For these reasons, and despite the fact that their role in migraine headaches has not been entirely elucidated, CGRP and its receptors have become desirable targets for antimigraine therapies. Fremanezumab is a humanized monoclonal antibody directed against endogenous CGRP - it interferes with the activity of CGRP, preventing its downstream effects and ultimately mitigating the development of migraine headaches.[L11749] |
| Toxicity | Information regarding overdose of fremanezumab is not readily available. The most common adverse events that led to discontinuation of fremanezumab therapy were injection site reactions including erythema, induration, and pain.[L11749] |
| Metabolism | Like other monoclonal antibodies, fremanezumab is expected to undergo enzymatic proteolysis into smaller peptides and amino acids.[L11749] |
| Absorption | Geometric mean ratios (GMRs) for Cmax for Japanese and Caucasian study subjects were 0.91, 1.04, and 1.14 for 225 mg, 675 mg, and 900 mg doses of fremanezumab [A33125]. GMRs for AUC (0-inf) were 0.96, 1.09, and 0.98, respectively [A33125]. Mean Tmax in a range of 5 to 11 days were similar across doses for both ethnicities as well [A33125]. |
| Fremanezumab has an apparent volume of distribution of approximately 6 liters which indicates very little distribution into tissue.[L11749] |
| Clearance | The apparent clearance of fremanezumab is 0.141 L/day.[L11749] |
| Categories | Antibodies, Monoclonal |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Calcitonin gene-related peptide 1,Calcitonin gene-related peptide 2 |
| Brand Name | Ajovy Filled Pen |
| Company | Teva |
| Brand Description | Teva |
| Prescribed For | Subcutaneous |
| Chemical Name | 225 mg |
| Formulation | AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema [see WARNINGS AND PRECAUTIONS]. |
| Physical Appearance | The most common side effects with Ajovy (which may affect more than 1 in 10 people) are reactions at the site of injection: pain, hardening (induration) and reddening of the skin (erythema). |
| Route of Administration | A chemical messenger called CGRP contributes to the development of migraine. Ajovy is a monoclonal antibody (a type of protein) designed to attach to CGRP and prevent it from binding to its target on the body’s cells thereby helping to prevent migraines from occurring. |
| Recommended Dosage | used to prevent migraine in adults who have migraines at least 4 days a month. |
| Contraindication | NA |
| Side Effects | NA |
| Useful Link 1 | Link |
| Useful Link 2 | Link |
| Remarks | NA |