• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Plegridy (peginterferon beta-1a)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Plegridy (peginterferon beta-1a)

  • Profile

Profile

Contact Information

Contact: Biogen
Website: https://www.plegridy.com/

Currently Enrolling Trials

    Show More

    General Information

    Plegridy (peginterferon beta-1a) is an injectable therapy, in which interferon beta-1a is pegylated to extend its half-life to permit a less frequent dosing schedule.

    Plegridy is specifically indicated for relapsing forms of multiple sclerosis  to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

    Plegridy is supplied as a solution for subcutaneous and intra-muscular administration. The recommended dosage of Plegridy is 125 micrograms injected subcutaneously every 14 days. Patients should start treatment with 63 micrograms on day 1. On day 15 (14 days later), the dose is increased to 94 micrograms, reaching the full dose of 125 micrograms on day 29 (after another 14 days). Patients should continue with the full dose (125 micrograms) every 14 days thereafter.

    Mechanism of Action

    Plegridy (peginterferon beta-1a) is a subcutaneous injectable therapy, in which interferon beta-1a is pegylated to extend its half-life to permit a less frequent dosing schedule. Interferon-beta (IFN-beta) is a polypeptide, normally produced by fibroblasts, that has antiviral and antiproliferative effects. Binding of IFN-beta to its receptor induces a complex transcriptional response. In immune cells (the most likely target of IFN-beta's therapeutic effect in MS), IFN-beta reduces antigen presentation and T-cell proliferation, alters cytokine and matrix metalloproteinase (MMP) expression, and restores suppressor function. Therapeutic forms of IFN-beta can be produced in bacterial expression systems (IFN-beta1b) or in mammalian cells (IFN-beta1a). The exact mechanism by which Plegridy  exerts its effects in patients with multiple sclerosis is unknown.

    Side Effects

    Adverse effects associated with the use of Plegridy may include, but are not limited to, the following:

    • injection site erythema
    • influenza-like illness
    • pyrexia
    • headache
    • myalgia
    • chills
    • injection site pain asthenia
    • injection site pruritus
    • arthralgia

    Clinical Trial Results

    The FDA approval of Plegridy was based on a randomized, double-blind, and placebo controlled, one-year study. The trial compared clinical and MRI outcomes at 48 weeks in patients who received Plegridy 125 micrograms (n=512) or placebo (n=500) subcutaneously once every 14 days. All subjects had a baseline Expanded Disability Status Scale (EDSS) score from 0 to 5, had experienced at least 2 relapses within the previous three years, and had experienced at least 1 relapse in the previous year. None of the subjects had progressive MS. Neurological evaluations were scheduled at baseline, every 12 weeks, and at the time of a suspected relapse. Brain MRI evaluations were scheduled at baseline, week 24, and week 48. The primary outcome was the annualized relapse rate over 1 year. The annualized relapse rate was 0.26 in the Plegridy arm and 0.40 in the placebo arm; relative reduction 36% (p=0.0007).

    Approval Date: 2014-08-01
    Company Name: Biogen
    Back to Listings

    Upcoming Events

    • 25Apr

      Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

    • 26Apr

      FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

    • 27Apr

      Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

    • 17May

      2023 WCG Avoca Quality Consortium Summit

    • 21May

      WCG MAGI Clinical Research Conference – 2023 East

    Featured Products

    • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

      Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    Featured Stories

    • Five Ws

      Consider the Five ‘W’s to Understand Potential Participants

    • QandA-360x240.png

      Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

    • White House

      Trial Stakeholders Advise White House on Emergency Research Infrastructure

    • SurveywBlueBackground-360x240.png

      Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing