API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
Europe
0
Canada
Australia
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
Details:
The safety of Eptinezumab-jjmr was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI. The most common adverse reactions in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity.
Lead Product(s): Eptinezumab
Therapeutic Area: Neurology Product Name: Vyepti
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:
Poster presentation of exploratory analysis from PROMISE 2 showed VYEPTI was associated with greater declines in headache frequency and days of acute headache medication use vs. placebo in people dually diagnosed with chronic migraine and medication overuse headache.
Lead Product(s): Eptinezumab
Therapeutic Area: Neurology Product Name: Vyepti
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 02, 2022
Details:
Vyepti is a humanized monoclonal antibody that binds to CGRP which was purposefully developed for IV administration met its primary endpoint of decrease in MMDs over weeks 1-12 in both episodic and chronic migraine.
Lead Product(s): Eptinezumab
Therapeutic Area: Neurology Product Name: Vyepti
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 01, 2021
Details:
Patients receiving VYEPTI reported a median time to headache pain freedom of 4 hours vs. 9 hours among those who received placebo, and a median time of 2 hours to the absence of their MBS vs. 3 hours with placebo.
Lead Product(s): Eptinezumab
Therapeutic Area: Neurology Product Name: Vyepti
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, 2021
Details:
VYEPTI met its primary endpoint of decrease in mean monthly migraine days (MMD) over months 1-3 in both episodic and chronic migraine. The safety of VYEPTI was evaluated in 2,076 patients with migraine who received at least one dose of VYEPTI.
Lead Product(s): Eptinezumab
Therapeutic Area: Neurology Product Name: Vyepti
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 03, 2021
Details:
Post-hoc closed testing analysis suggests onset of a migraine preventive effect with intravenous VYEPTI as early as day 1 following the initial dose.
Lead Product(s): Eptinezumab
Therapeutic Area: Neurology Product Name: Vyepti
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 13, 2020
Details:
Orsini Pharmaceutical has been selected as one of a very limited number of distribution partners for VYEPTI™ (eptinezumab-jjmr).
Lead Product(s): Eptinezumab
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Orsini Specialty Pharmacy
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 22, 2020