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Details:
Repatha (evolocumab) inhibits PCSK9 protein and prevents it from binding to the LDL receptor (LDLR), allowing LDLR to recycle back to the liver. By inhibiting the protein, the drug increases the number of LDLRs to clear from the blood, reducing LDL levels.
Lead Product(s): Evolocumab
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Repatha
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 01, 2023
Details:
FOURIER is part of Amgen's PROFICIO (Program to Reduce LDL-C and cardiovascular Outcomes Following Inhibition of PCSK9 In different populations) program of clinical studies investigating the impact of Repatha® on LDL-C and CVD across multiple populations.
Lead Product(s): Evolocumab
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Repatha
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 29, 2022
Details:
FOURIER-OLE studies are longest trials with PCSK9i to date, with patients receiving Repatha (evolocumab) for a median of 5 years and some patients receiving Repatha continuously for up to 8.5 years across the FOURIER and OLE study period.
Lead Product(s): Evolocumab
Therapeutic Area: Genetic Disease Product Name: Repatha
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 22, 2022
Details:
Repatha, a human mAB that inhibits proprotein convertase subtilisin/kexin type 9, showed sustained reduction in LDL-C with no new safety findings in Phase 3 FOURIER cardiovascular outcomes trial.
Lead Product(s): Evolocumab
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Repatha
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 27, 2022
Details:
Repatha® (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) for the treatment of homozygous familial hypercholesterolemia (HoFH) for younger pediatric patients.
Lead Product(s): Evolocumab
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Repatha
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 24, 2021
Details:
New positive phase 3 data for repatha in ACS patients who initiated treatment in the acute setting. Repatha in addition to optimized statin therapy improves features of plaque morphology twice as well as statins alone.
Lead Product(s): Evolocumab
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Repatha
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 August 27, 2021
Details:
The studies provide the body of evidence for treatment in a variety of high-risk patients and contributed to Repatha being approved in more than 75 countries. Notably, Amgen recently passed the milestone of more than one million patients receiving Repatha worldwide.
Lead Product(s): Evolocumab
Therapeutic Area: Infections and Infectious Diseases Product Name: Repatha
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 May 11, 2021
Details:
Notable abstracts include data from the first randomized controlled Phase 3 study of a PCSK9 inhibitor, Repatha, in pediatric patients with heterozygous familial hypercholesterolemia (HeFH), which will be presented as a late-breaking abstract in an oral presentation.
Lead Product(s): Evolocumab
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Repatha
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 25, 2020
Details:
Amgen Astellas BioPharma and Astellas have worked on Repatha for familial hypercholesterolemia, BLINCYTO and EVENITY. Under acquisition, Amgen Astellas BioPharma will change its name to Amgen K.K., and simultaneously relocate its Headquarters to Tokyo Midtown.
Lead Product(s): Evolocumab
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Repatha
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Amgen Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition January 23, 2020