The Rheumatologist
COVID-19 NewsACR Convergence
  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed
  • Home
  • Conditions
    • Rheumatoid Arthritis
    • SLE (Lupus)
    • Crystal Arthritis
      • Gout Resource Center
    • Spondyloarthritis
    • Osteoarthritis
    • Soft Tissue Pain
    • Scleroderma
    • Vasculitis
    • Systemic Inflammatory Syndromes
    • Guidelines
  • Resource Centers
    • Axial Spondyloarthritis Resource Center
    • Gout Resource Center
    • Psoriatic Arthritis Resource Center
    • Rheumatoid Arthritis Resource Center
    • Systemic Lupus Erythematosus Resource Center
  • Drug Updates
    • Biologics & Biosimilars
    • DMARDs & Immunosuppressives
    • Topical Drugs
    • Analgesics
    • Safety
    • Pharma Co. News
  • Professional Topics
    • Ethics
    • Legal
    • Legislation & Advocacy
    • Career Development
      • Certification
      • Education & Training
    • Awards
    • Profiles
    • President’s Perspective
    • Rheuminations
    • Interprofessional Perspective
  • Practice Management
    • Billing/Coding
    • Quality Assurance/Improvement
    • Workforce
    • Facility
    • Patient Perspective
    • Electronic Health Records
    • Apps
    • Information Technology
    • From the College
    • Multimedia
      • Audio
      • Video
  • Resources
    • Issue Archives
    • ACR Convergence
      • Gout Resource Center
      • Axial Spondyloarthritis Resource Center
      • Psoriatic Arthritis
      • Abstracts
      • Meeting Reports
      • ACR Convergence Home
    • American College of Rheumatology
    • ACR ExamRheum
    • Research Reviews
    • ACR Journals
      • Arthritis & Rheumatology
      • Arthritis Care & Research
      • ACR Open Rheumatology
    • Rheumatology Image Library
    • Treatment Guidelines
    • Rheumatology Research Foundation
    • Events
  • About Us
    • Mission/Vision
    • Meet the Authors
    • Meet the Editors
    • Contribute to The Rheumatologist
    • Subscription
    • Contact
  • Advertise
  • Search
You are here: Home / Articles / Rheumatology Drug Updates: Abaloparatide Promising for Osteoporosis, Plus Secukinumab for Ankylosing Spondylitis

Rheumatology Drug Updates: Abaloparatide Promising for Osteoporosis, Plus Secukinumab for Ankylosing Spondylitis

October 10, 2016 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF

Abaloparatide for Osteoporosis

thr_2016_october_pp64_01Abaloparatide is completing Phase III clinical trials for the potential treatment of postmenopausal osteoporosis in women who are at an increased risk of fracture.1 Abaloparatide is a synthetic peptide that engages the parathyroid hormone receptor and has favorable bone building activity. Abaloparatide has completed Phase 3 development for use as a daily self-administered injection (abaloparatide-SC). The New Drug Application for abaloparatide-SC was submitted to the U.S. Food and Drug Administration at the end of the first quarter of 2016. The Prescription Drug User Fee Act date of March 30, 2017, has been set for this agent’s review.

You Might Also Like
  • Abaloparatide Promising for Osteoporosis; NICE Draft Guidelines Include Secukinumab for Ankylosing Spondylitis
  • Abaloparatide vs. Alendronate for Osteoporosis
  • Abaloparatide May Boost BMD in Older Women with Osteoporosis
Explore This Issue
October 2016
Also By This Author
  • The FDA Denies Approval for Remoxy Extended Release; Plus Knee OA Pain Treatment Moves into Phase 3 Trials

Results from the Phase 3 double-blind, randomized, controlled, ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial were recently published in the Journal of the American Medical Association.2 This clinical trial enrolled 2,463 patients to evaluate the safety and efficacy of abaloparatide for treating postmenopausal women with osteoporosis. Blinded, daily subcutaneous injections of placebo (n=821), 80 μg abaloparatide (n=824) or 20 μg open-label teriparatide (n=818) were administered for 18 months.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

The study enrolled women with bone mineral density T score ≤−2.5 and >−5.0 at the lumbar spine or femoral neck, and with radiological evidence ≥2 mild or ≥1 moderate lumbar or thoracic vertebral fracture, or a history of a low-trauma, non-vertebral fracture within the prior five years. Additionally, postmenopausal women over 65 years old with fracture criteria and a T score ≤−2.0 and >−5.0, or without fracture criteria and a T score ≤−3.0 and >−5.0, could also enroll. In all, 1,901 women completed the study.

Increases in bone mineral density were greater in the abaloparatide-treated patients than in placebo-treated patients (P<0.001). In addition, the incidence of hypercalcemia was lower in abaloparatide-treated patients (3.4%) compared with teriparatide-treated patients (6.4%). The results of this trial showed that patients treated daily with abaloparatide for 18 months had a significantly greater reduction in the incidence of new vertebral fractures (P<0.001) and non-vertebral fractures (P=0.049) compared with placebo.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

A transdermal formulation of abaloparatide is also being evaluated in clinical trials for potential use as an osteoporosis treatment.1

NICE Draft Guidance

New draft guidance from the National Institute for Health and Care Excellence (NICE) means patients in the U.K. with ankylosing spondylitis will have access to the interleukin (IL) 17A inhibitor, secukinumab (Cosentyx).3 Secukinumab was licensed for use in the U.K. in May and is the first in a new class of drugs to treat the condition. The drug helps reduce inflammation and pain, and improves mobility. It comes in pre-filled pen syringes for self-administration.

Pages: 1 2 3 | Single Page

Filed Under: Conditions, Drug Updates, Spondyloarthritis Tagged With: abaloparatide, Ankylosing Spondylitis, Approval, clinical trial, drug, FDA, Osteoporosis, Rheumatic Disease, rheumatology, Safety, secukinumabIssue: October 2016

You Might Also Like:
  • Abaloparatide Promising for Osteoporosis; NICE Draft Guidelines Include Secukinumab for Ankylosing Spondylitis
  • Abaloparatide vs. Alendronate for Osteoporosis
  • Abaloparatide May Boost BMD in Older Women with Osteoporosis
  • Infliximab-abda Becomes 5th Biosimilar Approved in the U.S. & Abaloparatide Approved for Osteoporosis

Patient & Caregiver Resources

Find a rheumatology provider. Learn about your condition and how to live with it. English and Spanish language resources.

View Patient & Caregiver Resources »

ACR Convergence

Don’t miss rheumatology’s premier scientific meeting for anyone involved in research or the delivery of rheumatologic care or services.

Visit the ACR Convergence site »

Rheumatology Research Foundation

The Foundation is the largest private funding source for rheumatology research and training in the U.S.

Learn more »

The Rheumatologist newsmagazine reports on issues and trends in the management and treatment of rheumatic diseases. The Rheumatologist reaches 11,500 rheumatologists, internists, orthopedic surgeons, nurse practitioners, physician assistants, nurses, and other healthcare professionals who practice, research, or teach in the field of rheumatology.

About Us / Contact Us / Advertise / Privacy Policy / Terms of Use / Cookie Preferences

  • Connect with us:
  • Facebook
  • Twitter
  • LinkedIn
  • YouTube
  • Feed

Copyright © 2006–2023 American College of Rheumatology. All rights reserved.

ISSN 1931-3268 (print)
ISSN 1931-3209 (online)