Amgen (AMGN) Highlights The Latest EVENITY™ (Romosozumab) And Prolia® (Denosumab) Research

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Amgen Highlights The Latest EVENITY™ (Romosozumab) And Prolia® (Denosumab) Research At The American Society For Bone And Mineral Research Annual Meeting

First Presentation of Detailed EVENITY ARCH Study Results and FRAME Extension Final Analysis

10-Year Data From Long-Term Prolia FREEDOM Study

 Amgen (AMGN) today announced that 19 scientific abstracts will highlight the latest scientific research on EVENITY™* (romosozumab) and Prolia® (denosumab) at this year’s Annual Meeting of the American Society for Bone and Mineral Research (ASBMR) in Denver from Sept. 8-11, 2017.

“The data being presented at ASBMR underscore our steadfast focus for more than a decade to advance scientific understanding and care for the millions of people living with osteoporosis,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Although those who suffer fractures often experience pain1 and face potential loss of their independence2, only about one-fifth of patients with a fracture are treated for the underlying disease3. We are pleased to share our latest research with the bone community as we work together to help solve the public health crisis in osteoporosis4.”

The congress will feature the first presentation of full results from the EVENITY Phase 3 active-comparator ARCH study. Three abstracts from the EVENITY Phase 3 placebo-controlled FRAME study of more than 7,000 postmenopausal women with osteoporosis will also be highlighted as oral presentations.  EVENITY is being co-developed by Amgen and UCB.

Prolia presentations will include new analyses from the Phase 3 FREEDOM study and its seven-year extension, including one that demonstrates 10-year continued nonvertebral fracture reduction. Additionally, data will be presented from the Phase 3 study in patients with glucocorticoid-induced osteoporosis (GiOP), as well as data demonstrating that treatment with Prolia prevents deterioration in the trabecular microstructure at the distal tibia.

ABSTRACTS OF INTEREST

EVENITY

Clinical

  • A Randomized Alendronate Controlled Trial of Romosozumab: Results of the Phase 3 ARCH Study (Active-controlled fracture study in postmenopausal women with osteoporosis at high risk)
    Abstract LB-1162, Oral Presentation, Monday, Sept. 11, 11:45 – 11:55 a.m. MT (Mile High Ballroom)
  • Continued Fracture Risk Reduction After 12 Months of Romosozumab Followed by Denosumab Through 36 Months in the Phase 3 FRAME (Fracture study in postmenopausal women with osteoporosis) Extension
    Abstract 1071, Oral Presentation, Sunday, Sept. 10, 9:45 – 10 a.m. MT (Mile High Ballroom)
  • FRAME Study: The Foundation Effect of Rebuilding Bone With One Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab
    Abstract 1110, Oral Presentation, Sunday, Sept. 10, 4:30 – 4:45 p.m. MT (Mile High Ballroom)
  • Effects  of  Romosozumab  in  Postmenopausal  Women  With Osteoporosis After  2  and 12 Months: Bone Histomorphometry Substudy
    Abstract 1072, Oral Presentation, Sunday, Sept. 10, 10 – 10:15 a.m. MT (Mile High Ballroom)
  • Effects  of  Romosozumab  in  Postmenopausal  Women  With Osteoporosis After 2 and 12 Months Assessed by MicroCT on Iliac Crest Bone Biopsies
    Abstract MO0128, Poster Presentation, Monday, Sept. 11noon – 2 p.m. MT (ASBMR Discovery Hall)

Prolia

Clinical

  • Ten-year Continued Nonvertebral Fracture Reduction in Postmenopausal Osteoporosis With Denosumab Treatment
    Abstract 1073, Oral Presentation, Sunday, Sept. 10, 10:15 – 10:30 a.m. MT (Mile High Ballroom)
  • Denosumab Treatment in Women with Osteoporosis Rapidly Prevents Deterioration in Trabecular Microstructure at the Distal Tibia
    Abstract 1033, Oral Presentation, Friday, Sept. 8, 2:30 – 2:45 p.m. MT (Mile High Ballroom)
  • Safety and Efficacy of Denosumab Among Subjects With Mild-to-Moderate Chronic Kidney Disease (CKD) in the “Fracture Reduction Evaluation of Denosumab in Osteoporosis every 6 Months” Extension Study
    Abstract 1070, Oral Presentation, Saturday, Sept. 9, 5:45 – 6 p.m. MT (Four Seasons Ballroom II-III)
  • Denosumab Reduced Bone Remodeling, Eroded  Surface, and Erosion Depth in Cortical Bone of Iliac Crest  Biopsies From Postmenopausal  Women in the FREEDOM Trial
    Abstract 1111, Oral Presentation, Sunday, Sept. 10, 4:45 – 5 p.m. MT (Mile High Ballroom) and was featured at the ASBMR Symposium: Current Concepts in Bone Fragility – From Cells to Surrogates, Thursday, Sept. 78 a.m. – 6:30 p.m. MT(Colorado Convention Center)
  • Evaluation of Invasive Oral Procedures and Events in Women With Postmenopausal Osteoporosis Treated for up to 10 Years With Denosumab: Results From the Phase 3 FREEDOM Open-label Extension
    Abstract 1016, Oral Presentation, Friday, Sept. 8, 1:45 – 2 p.m. MT (Mile High Ballroom)
  • Effect of Denosumab Compared With Risedronate on Percentage Change in Lumbar Spine BMD at 12 Months  in Subgroups of Glucocorticoid-treated Individuals
    Abstract F0118 and SA0118, Plenary Poster, Friday, Sept. 8, 5 – 7 p.m. MT and Saturday, Sept. 9, 12:30 – 2:30 p.m. MT (ASBMR Discovery Hall – Exhibit Hall A)
  • A Meta-Analysis of 4 Clinical Trials of Denosumab Compared With Bisphosphonates in Postmenopausal Women Previously Treated With Oral Bisphosphonates
    Abstract SU0010, Poster Presentation, Sunday, Sept. 10, 12:30 – 2:30 p.m. MT(ASBMR Discovery Hall – Exhibit Hall A)
  • Bone Matrix Mineralization After Denosumab Treatment Discontinuation
    Abstract LB-MO0368, Poster Presentation, Monday, Sept. 11, noon – 2 p.m. MT(ASBMR Discovery Hall – Exhibit Hall A & B1)

Observational/Health Economics

  • Medication Persistence and Risk of Fracture Among Female Medicare Beneficiaries Diagnosed with Osteoporosis
    Abstract 1035, Oral Presentation, Friday, Sept. 8, 3 – 3:15 p.m. MT (Mile High Ballroom)
  • Incidence Rates of Acute Events Leading to Hospitalization or Emergency Room Visit Among Postmenopausal Women Receiving Treatment for Osteoporosis
    Abstract MO0173, Poster Presentation, Monday, Sept. 11, noon – 2 p.m. MT (ASBMR Discovery Hall – Exhibit Hall A)
  • Methodological Considerations in Evaluating Treatment Differences in Fracture Outcomes Among Female Medicare Beneficiaries Initiating Osteoporosis Medications
    Abstract SU0208, Poster Presentation, Sunday, Sept. 10, 12:30 – 2:30 p.m. MT(ASBMR Discovery Hall – Exhibit Hall A)

Disease State

Observational

  • Predictors of Near-Term Non-Vertebral Fracture in Elderly Women with Osteoporosis, Osteopenia, or a History of Fracture, Based on Data from the Canadian Multicentre Osteoporosis Study (CaMos)
    Abstract FR0264 and SA0264, Plenary Poster, Friday, Sept. 8, 5 – 7 p.m. MT and Saturday, Sept. 9, 12:30 – 2:30 p.m. MT (ASBMR Discovery Hall – Exhibit Hall A)
  • Changes in Bone Mineral Density (BMD): A Longitudinal Study of Osteoporosis Patients
    Abstract SA0072, Poster Presentation, Saturday, Sept. 9, 12:30 – 2:30 p.m. MT(ASBMR Discovery Hall – Exhibit Hall A)
  • Testing an Evidence-based Theoretical Model of Imminent (1-year) Fracture Risk in Elderly Women: Results from the Canadian Multicentre Osteoporosis Study (CaMOS)
    Abstract SU0316, Poster Presentation, Sunday, Sept. 10, 12:30 – 2:30 p.m. MT(ASBMR Discovery Hall – Exhibit Hall A)

About the ARCH study
ARCH (Active-contRolled FraCture Study in Postmenopausal Women with Osteoporosis at High Risk of Fracture) is a Phase 3 multicenter, international, randomized, double-blind, alendronate-controlled study of EVENITY in postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history. The study evaluated 12 months of EVENITY treatment followed by at least 12 months of alendronate treatment, compared with alendronate treatment alone. The purpose of this study was to determine if EVENITY treatment is effective in reducing the incidence of clinical fracture (non-vertebral fracture and clinical vertebral fracture) and new vertebral fracture. The incidence of clinical fracture was event-driven and the primary analysis occurred when 330 fractures occurred or the last patient was on the study for 24 months, whichever was later.

Patients (4,093) were randomized 1:1 to receive either 210 mg EVENITY subcutaneously every month or 70 mg alendronate orally every week for the duration of the 12-month double-blind alendronate-controlled study period. After the double-blind active-comparator study period, patients received alendronate while remaining blinded to their initial treatment assignment.

About the FRAME study
FRAME (FRActure study in postmenopausal woMen with ostEoporosis) is a multicenter, international, randomized, double-blind, placebo-controlled, parallel-group study in postmenopausal women with osteoporosis, defined as low bone mineral density at the total hip or femoral neck. The study evaluated the effectiveness of EVENITY treatment, compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also further evaluated if EVENITY treatment for 12 months followed by denosumab treatment for 12 months, compared with placebo followed by denosumab treatment, was effective in reducing the risk of new vertebral fractures through 24 months. In addition, clinical fracture (a composite endpoint which encompasses all symptomatic fractures, both non-vertebral and painful vertebral fractures) risk reduction, non-vertebral fracture (fractures outside of the spine, excluding sites that are not considered osteoporotic, fractures due to high trauma or pathologic fractures) risk reduction and other endpoints were assessed at 12 and 24 months.

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