Amgen to present data on Repatha (evolocumab) and observational studies at ESC Congress 2015

AmgenAug 26 2015

Amgen (NASDAQ: AMGN) today announced that it will present six abstracts at the upcoming ESC Congress 2015, organized by the European Society of Cardiology, being held Aug. 29 – Sept. 2 in London. Data will be presented evaluating Repatha^TM (evolocumab), a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor approved in the European Union (EU) for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction.

"This has been a historic year for Amgen's cardiovascular franchise with multiple regulatory milestones, including the recent EU approval of Repatha, the first PCSK9 inhibitor approved by a regulatory agency in the world, and we're excited to continue the momentum with new data being presented at this year's ESC Congress," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are committed to continuing to evaluate Repatha and look forward to sharing long-term safety and efficacy data in patients who are unable to tolerate effective doses of statins, as well as findings on consistent LDL-C reductions in different patient subgroups."

In addition to clinical results, data from Amgen's Center for Observational Research will also be presented, including a Rapid Fire Abstract presentation on statin usage and outcomes among Medicare beneficiaries, a presentation on the identification and characterization of patients with heterozygous familial hypercholesterolemia (HeFH), and a discussion examining the burden of cardiovascular hospitalizations in patients who have had a myocardial infarction. In addition, Global Health Economic (GHE) data on the identification and management of patients who cannot tolerate statins will be presented.

Amgen-sponsored abstracts and satellite symposium at ESC Congress 2015 include:

Repatha

• Clinical equivalence of evolocumab among patient subgroups in PROFICIO: a pooled analysis of 3146 patients from phase 3 studies
  Abstract P1756, Poster Presentation, Sunday, Aug. 30, 8:30 a.m.-12:30 p.m. BST (Poster Area)
• Long-term safety and efficacy of evolocumab in patients with statin intolerance
  Abstract P5968, Moderated Poster Presentation, Tuesday, Sept. 1, 3:47-3:55 p.m. BST (Moderated Poster Station – Poster Area)
• Satellite Symposium – PCSK9 inhibition: an important step forward in treating dyslipidemia in high-risk patients
  Tuesday, Sept. 1, 12:45-1:45 p.m. BST (Ankara – Village 7)

Observational Research

• Burden of cardiovascular hospitalizations following myocardial infarction among older adults
  Abstract P3667, Poster Presentation, Monday, Aug. 31, 8:30 a.m.-12:30 p.m. BST (Poster Area)
• Identification and characterization of heterozygous familial hypercholesterolemia patients using the Vanderbilt University Medical Center Synthetic Derivative database
  Abstract P5374, Poster Presentation, Tuesday, Sept. 1, 8:30 a.m.-12:30 p.m. BST (Poster Area)
• Patterns of statin use and outcomes following myocardial infarction among Medicare beneficiaries
  Abstract P6653, Rapid Fire Abstract Presentation, Wednesday, Sept. 2, 9:33-9:42 a.m. BST (Victoria Park – The Hub)

Health Economics

• Identification and management of statin-intolerance: a survey of clinicians from 13 countries
  Abstract P1677, Poster Presentation, Sunday, Aug. 30, 8:30 a.m.-12:30 p.m. BST (Poster Area)