The Rheumatologist
COVID-19 News
  • 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
    • Ankylosing Spondylitis Resource Center
    • Gout 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
  • 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
      • Systemic Lupus Erythematosus Resource Center
      • Rheumatoid Arthritis Resource Center
      • Gout Resource Center
      • 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: Efficacy Studied Following Accelerated Drug Approvals; Plus Secukinumab Meets Benchmark for Psoriasis

Rheumatology Drug Updates: Efficacy Studied Following Accelerated Drug Approvals; Plus Secukinumab Meets Benchmark for Psoriasis

November 9, 2017 • By Michele B. Kaufman, PharmD, BCGP

  • Tweet
  • Email
Print-Friendly Version / Save PDF
ajt/shutterstock.com

ajt/shutterstock.com

Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent years, the number of drugs that have received FDA accelerated approval has increased.

You Might Also Like
  • Efficacy Studied Following Accelerated Drug Approvals
  • Secukinumab Meets 5-Year Benchmark for Psoriasis
  • Rheumatology Drug Updates: Efficacy & Safety of Guselkumab, Plus FX006 for Knee OA
Explore This Issue
November 2017
Also By This Author
  • Drug Updates

When drugs undergo the accelerated approval process, the concern is that the safety and efficacy of these agents are not well established. Additional concern exists because this safety and efficacy information may not be confirmed during three-year, post-drug-approval trials. Some clinicians believe the drugs undergoing the accelerated approval process may pose a greater risk to patients, while others look toward proven effectiveness, rather than just surrogate markers of efficacy.

ad goes here:advert-1
ADVERTISEMENT
SCROLL TO CONTINUE

In a recent study, researchers evaluated the characteristics of drugs that received FDA accelerated approval between 2009 and 2013.1 They reviewed publicly available FDA documents used in the preapproval trials that led to the accelerated drug approvals to determine the characteristics of the drugs receiving this approval. The FDA’s post-marketing database of requirements, commitments and matched, peer-reviewed publications was also used to obtain needed information. The study follow-up ended on April 7, 2017. Its design features a comparison of the preapproval and confirmatory studies. Subsequent regulatory decisions and estimated time between accelerated approval and fulfillment of regulatory requirements were also summarized.

The Results: During the evaluated timeframe, the FDA granted accelerated approval to 22 drugs for 24 indications, with 38 preapproval studies supporting 24 indications. Nineteen indications were for oncologic treatment. Of the required post-approval confirmatory studies, 19 of 38 (50%) were completed in a minimum of three years post-approval. Of these studies, most showed some treatment benefit, but relied on surrogate measures rather than clinical outcomes. Twenty-five of the 38 (66%) studies observed clinical efficacy, seven (18%) evaluated longer follow-up and six (16%) evaluated safety. The proportion of randomized studies did not differ before and after accelerated approval.

ad goes here:advert-2
ADVERTISEMENT
SCROLL TO CONTINUE

Efficacy was demonstrated for 10 of 24 (42%) indications in completed studies that used surrogate measures. As a result, the package inserts (e.g., drug labels) of these medications were updated. Of the 14 of 24 (58%) indications that had not completed all the requirements, at least one of the confirmatory studies did not demonstrate a clinical benefit, two (8%) were terminated and three (13%) were delayed by more than one year.

Pages: 1 2 3 | Single Page

Filed Under: Conditions, DMARDs & Immunosuppressives, Drug Updates, Spondyloarthritis Tagged With: accelerated approval, Ankylosing Spondylitis, Clinical, drug, efficacy, FDA, Medication, outcome, Psoriasis, Psoriatic Arthritis, Research, rheumatology, Safety, secukinumab, study, Treatment, trialIssue: November 2017

You Might Also Like:
  • Efficacy Studied Following Accelerated Drug Approvals
  • Secukinumab Meets 5-Year Benchmark for Psoriasis
  • Rheumatology Drug Updates: Efficacy & Safety of Guselkumab, Plus FX006 for Knee OA
  • Hydrocodone Bitartrate, Secukinumab, Varenicline Updates, Trials, Approvals

Meeting Abstracts

Browse and search abstracts from the ACR Convergence and ACR/ARP Annual Meetings going back to 2012.

Visit the Abstracts site »

American College of Rheumatology

Visit the official website for the American College of Rheumatology.

Visit the ACR »

Simple Tasks

Learn more about the ACR’s public awareness campaign and how you can get involved. Help increase visibility of rheumatic diseases and decrease the number of people left untreated.

Visit the Simple Tasks site »

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

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

Copyright © 2006–2021 American College of Rheumatology. All rights reserved.

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

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.