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

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

Enspryng (satralizumab-mwge)

  • Profile

Profile

Contact Information

Contact: Genentech
Website: https://www.enspryng.com/

Currently Enrolling Trials

    Show More

    General Information

    Enspryng (satralizumab-mwge) is an interleukin-6 (IL-6) receptor antagonist.

    Enspryng is specifically indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

    Assessments prior to the first dose of Enspryng should include screenings for hepatitis B, tuberculosis and liver transaminases. Because vaccination with live-attenuated or live vaccines is not recommended during treatment with Enspryng, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of Enspryng for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of Enspryng for non-live vaccines. 

    Enspryng is supplied as an injection for subcutaneous administration. The recommended loading dosage of Enspryng for the first three administrations is 120 mg by subcutaneous injection at Weeks 0, 2, and 4, followed by a maintenance dosage of 120 mg every 4 weeks. Please see the drug label for recommended doses for missed or delayed treatments.

    Mechanism of Action

    Enspryng (satralizumab-mwge) is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. The precise mechanism by which satralizumab-mwge exerts therapeutic effects in NMOSD is unknown but is presumed to involve inhibition of IL-6-mediated signaling through binding to soluble and membrane-bound IL-6 receptors.

    Side Effects

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

    • nasopharyngitis
    • headache
    • upper respiratory tract infection
    • gastritis
    • rash
    • arthralgia
    • extremity pain
    • fatigue
    • nausea

    Clinical Trial Results

    The FDA approval of Enspryng was based on results from two randomized controlled Phase III clinical trials, the SAkuraStar and SAkuraSky studies.

    SAkuraStar was a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Enspryng monotherapy. Ninety-five adult patients were randomized to either of the following two treatment groups in a 2:1 ratio: Enspryng (120 mg) or placebo. Both treatments were administered subcutaneously at week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals. The double-blind treatment period ended at 1.5 years after the enrollment of the last patient.The primary endpoint is the time to first protocol-defined relapse (PDR), adjudicated by an independent review committee in the double-blind period. The time to first relapse was significantly longer in Enspryng treated patients compared to patients who received placebo (risk reduction 55%). In the anti-AQP4 antibody positive population, there was a 74% risk reduction. There was no evidence of a benefit in the anti-AQP4 antibody negative patients.

    SAkuraSky was a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Enspryng added to baseline immunosuppressant therapy in patients with NMOSD. Seventy-six adult patients were randomized to either of the following two treatment groups in a 1:1 ratio: Enspryng (120 mg) or placebo added to baseline therapy (azathioprine, mycophenolate mofetil and/or corticosteroids). Both treatments were administered subcutaneously at week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals. The double-blind treatment period ended when patients experienced a PDR; the study ended when the total number of PDRs reached 26. The primary endpoint was the time to first PDR as adjudicated by an independent review committee in the double-blind period. The time to the first confirmed relapse was significantly longer in patients treated with Enspryng compared to patients who received placebo (risk reduction 62%). In the anti-AQP4 antibody positive population, there was a 78% risk reduction. There was no evidence of a benefit in the anti-AQP4 antibody negative patients.

    Approval Date: 2020-08-01
    Company Name: Genentech
    Back to Listings

    Upcoming Events

    • 16Feb

      Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

    • 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

    • SurveywBlueBackground-360x240.png

      Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

    • TrendsInsights2023-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Two

    • TimeMoneyEffort-360x240.png

      Time is Money and So Is Effort, Budgeting Experts Say

    • TrendsInsights2023A-360x240.png

      WCG Clinical Research Trends and Insights for 2023, Part Three

    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