Amgen to highlight new data for investigational cholesterol-lowering medication evolocumab

Amgen (NASDAQ: AMGN) today announced that it will present 13 abstracts at the upcoming American Heart Association (AHA) Scientific Sessions 2014 being held Nov. 15-19 in Chicago, including data from studies evaluating evolocumab, an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.¹

“We will be sharing diverse data exploring the potential clinical utility of evolocumab at this year’s AHA Scientific Sessions, including multiple new analyses that examine longer-term treatment with evolocumab, the effect on different lipid parameters and the efficacy of two dosing regimens,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “The medical community is keenly aware of the significant unmet need for many patients with high cholesterol, and we are continuing to work with regulatory agencies on the global filing packages we have submitted, including in the U.S. and EU.”

Several of the abstracts are from the large and comprehensive evolocumab clinical trial program, PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different POpulations).

Data to be presented at the AHA Scientific Sessions 2014 include:

Clinical Development

• Long-Term Reduction in Lipoprotein (a) With the PCSK9 Monoclonal Antibody Evolocumab (AMG 145): A Pooled Analysis of 3278 Patients in Phase 2, 3, and Open Label Extension Studies
  Abstract 15743, Abstract Poster Session, Monday, Nov. 17, 9:30-11 a.m. CST (South Hall A2 – Core 2)
• Evaluation of the Relationship Between Evolocumab 140 mg Every Two Weeks and 420 mg Monthly Dosing Regimens
  Abstract 16270, Abstract Poster Session, Monday, Nov. 17, 9:30-11 a.m. CST (South Hall A2 – Core 2)
• Effects of Evolocumab Treatment on Serum Adrenal and Gonadal Hormone Levels: Results from the 52-week, Phase 3, Double-blind, Randomized, Placebo-controlled DESCARTES Study
  Abstract 17005, Abstract Poster Session, Monday, Nov. 17, 9:30-11 a.m. CST (South Hall A2 – Core 2)
• Trial Assessing Long-Term Use of PCSK9 Inhibition in Patients with Genetic LDL Disorders (TAUSSIG): Efficacy and Safety in Patients with Homozygous Familial Hypercholesterolemia Receiving Lipid Apheresis
  Abstract 17016, Abstract Poster Session, Tuesday, Nov. 18, 9:30-11 a.m. CST (South Hall A2 – Core 2)
• The Diagnosis of Heterozygous Familial Hypercholesterolemia: Genotype versus Phenotype 
  Abstract 17368, Abstract Poster Session, Tuesday, Nov. 18, 9:30-11 a.m. CST (South Hall A2 – Core 2) 
• Impact of Baseline PCSK9 Levels on the Efficacy of Evolocumab, a Monoclonal Antibody Against PCSK9 
  Abstract 16196, Abstract Poster Session, Tuesday, Nov. 18, 3-4:30 p.m. CST (South Hall A2 – Core 2) 
• Safety and Tolerability of Very Low LDL-C Levels in Patients Treated with 52 Weeks of Evolocumab (AMG 145)
  Abstract 16865, Abstract Poster Session, Tuesday, Nov. 18, 3-4:30 p.m. CST (South Hall A2 – Core 2)

Early Development

• Statin-Induced Myopathy is Mediated by Isoprenoid Depletion and is Independent of Serum Cholesterol Levels
  Abstract 13907, Abstract Poster Session, Sunday, Nov. 16, 9:30-11 a.m. CST (South Hall A2 – Core 2) 
• Effects of Evolocumab (AMG 145) as a Monotherapy or in Combination with Statins on Lipoprotein Particles and Subclasses
  Abstract 16955, Abstract Poster Session, Wednesday, Nov. 19, 9:30-11 a.m. CST (South Hall A2 – Core 7)

Sponsored Research

• PCSK9 is Elevated in HIV+ Patients
  Abstract 17751, Abstract Oral Session, Saturday, Nov. 15, 2:15-2:25 p.m. CST (Room S406A)

Observational Research

• Statin Prescription and Dose Intensity Among Elderly Medicare Beneficiaries, by CV Disease Diagnosis and Prescriber Specialty
  Abstract 15677, Abstract Poster Session, Monday, Nov. 17, 9:30-11 a.m. CST (South Hall A2 – Core 2) 
• Low Density Lipoprotein Cholesterol Response and Statin Persistence among Patients with High Coronary Heart Disease Risk Initiating Treatment
  Abstract 18986, Abstract Poster Session, Monday, Nov. 17, 9:30-11 a.m. CST (South Hall A2 – Core 2)

Health Economics

• Work Absenteeism, Short Term Disability and Related Indirect Costs Associated with Cardiovascular Events and Related Clinical Procedures
  Abstract 13352, Abstract Poster Session, Sunday, Nov. 16, 9:30-11 a.m. CST (South Hall A2 – Core 2)

References

1. Amgen Data on File, Investigator Brochure.
2. Abifadel M, Varret M, Rabes JP, et al. Mutations in PCSK9 Cause Autosomal Dominant Hypercholesterolemia. Nat Genet. 2003;34:154-156.