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Details:
Ajovy is a FDA approved, humanized monoclonal antibody (mAb) which selectively binds the calcitonin gene-related peptide (CGRP). It is being investigated for the prevention of migraine in adult Chinese patients.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 11, 2024
Details:
AJOVY (Fremanezumab-vfrm) is a subcutaneous injection of the anti-CGRP (calcitonin gene-related peptide) monoclonal antibody, which is produced by recombinant DNA technology.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2022
Details:
AJOVY is a subcutaneous injection of the anti-CGRP monoclonal antibody (fremanezumab), which is produced by recombinant DNA technology. CGRP is thought to play an important role in migraine attacks. Ajovy targets the CGRP ligand, inhibiting its binding to the CGRP receptor.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2022
Details:
The real-world effectiveness of Ajovy (fremanezumab) in patients with refractory migraine from a US tertiary headache center who switched from erenumab study was also highlighted.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2022
Details:
AJOVY (fremanezumab) is indicated for the preventive treatment of migraine in adults who have at least four migraine days per month, is a subcutaneous injection for the preventive treatment of migraine in adults who have at least four migraine days per month.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2022
Details:
Real-world data will be presented regarding reductions in acute medication use for migraine patients initiating Ajovy, a calcitonin gene-related peptide antagonist, as well as a study evaluating healthcare resource use of patients initiating Ajovy.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2022
Details:
Extension analyses observed patients taking AJOVY experienced a reduction in migraine and headache days and evaluated disability and health-related quality of life.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 30, 2021
Details:
AJOVY is the first long-acting (defined as efficacy measured over a 12-week period following a 675 mg [225 mg x 3] subcutaneous dose) anti-CGRP subcutaneous injection approved for the preventive treatment of migraine in adults with both quarterly and monthly dosing options.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2021
Details:
Late-breaking data being presented include a fixed-effect Bayesian network meta-analysis (NMA) assessing relative efficacy for monthly and quarterly AJOVY, daily and twice daily Atogepant and every other day Rimegepant for the preventive treatment of episodic migraine (EM).
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2021
Details:
Combined review of Phase 3 studies with fremanezumab indicates positive cardiovascular safety profile in adult patients. Additional data on injection-related adverse reactions provide new guidance to healthcare professionals for the optimal selection of injection sites.
Lead Product(s): Fremanezumab
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Ajovy
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2021
Details:
Fremanezumab is an anti-CGRP monoclonal antibody, administered as a subcutaneous injection for the prevention of chronic and episodic migraine attacks. NDA has been applied for the indication of preventive treatment of migraine.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 29, 2020
Details:
Open-label extension of the FOCUS Phase IIIb study examined changes in quality of life, health status, depressive symptoms and work productivity over 12 weeks.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Ajovy
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 18, 2020
Details:
Preliminary trial results indicated that primary endpoints were achieved with statistical significance versus placebo for subjects with chronic migraine and episodic migraine, respectively.
Lead Product(s): Fremanezumab
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase II/ Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 27, 2020
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