DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/qwqxrh/pcsk9_inhibitors) has announced the addition of the "PCSK9 inhibitors - A new class of LDL-cholesterol lowering agents" report to their offering.
Several agents that inhibit PSCK9 are in development for the treatment of hypercholesterolemia. PSCK9 destroys LDL-cholesterol receptors on cell surfaces. By blocking destruction of that LDL-receptor, PSCK9 inhibitors facilitate removal of LDL-cholesterol from the blood. Regeneron and Amgen both have agents in this class respectively, REGN727 and AMG 145, that are in advanced stages of clinical development.
Accordingly, this report looks at the underlying science. It also evaluates the two clinical programs for evidence of efficacy and safety found in the data, and also from the perspective of regulatory approval and the labels that the programs may or may not support. Related, it also assesses the market niches into which they best fit and the competitive profiles of the two.
Key Topics Covered:
Lipid metabolism-an overview
Regeneron and Sanofi's REGN727 (SAR236553, Alirocumab)
Amgen's AMG 145
Clinical and Regulatory Discussion
- Market overview
- Competitive issues
Appendix 1. ATP III National Cholesterol Education Program treatment Guidelines-Adapted
Appendix 2. Treatment emergent adverse events during a 12 week study of REGN727 therapy in Heterozygous familial hypercholesterolemia patients
Appendix 3. Zetia NDA trials
Appendix 4. Summary of mipomersen trials
- Alnylam/The Medicines Company
- Bristol-Meyers Squibb
- Eli Lilly
For more information visit http://www.researchandmarkets.com/research/qwqxrh/pcsk9_inhibitors
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