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From LBR-101 to Fremanezumab for Migraine.
Marcelo E Bigal1, Alan M Rapoport2, Stephen D Silberstein3
1Purdue Pharma, 201 Tresser Boulevard, Stamford, CT, 06901, USA. marcelo.bigal@pharma.com.
CNS Drugs
|October 13, 2018
Summary
Fremanezumab, a monoclonal antibody targeting calcitonin gene-related peptide (CGRP), offers effective preventive treatment for chronic migraine. Its development validates CGRP
Area of Science:
- Neurology
- Pharmacology
- Immunology
Background:
- Calcitonin gene-related peptide (CGRP) plays a crucial role in migraine pathogenesis.
- CGRP receptor antagonists and monoclonal antibodies targeting CGRP or its receptor have emerged as effective migraine treatments.
- Fremanezumab is a humanized IgG2a monoclonal antibody developed to target CGRP.
Purpose of the Study:
- To provide an in-depth review of the development of Fremanezumab.
- To summarize Fremanezumab's in vitro and in vivo pharmacology and Phase I studies.
- To review late-stage clinical development, efficacy, safety, and compare it with other CGRP antibodies.
Main Methods:
- Review of in vitro and in vivo pharmacology studies.
- Analysis of Phase I clinical trial data.
- Evaluation of late-stage clinical development, including efficacy and safety data from pivotal trials.
- Comparative analysis with other CGRP-targeting monoclonal antibodies.
Main Results:
- Fremanezumab demonstrates efficacy in the preventive treatment of episodic and chronic migraine.
- The development and approval of Fremanezumab validate the role of CGRP in migraine.
- Fremanezumab exhibits a favorable safety profile in clinical studies.
Conclusions:
- Fremanezumab represents a significant advancement in migraine prevention.
- Targeting CGRP is a validated therapeutic strategy for migraine.
- Further research into CGRP pathways may reveal new therapeutic avenues for migraine management.
