• 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
    • JobWatch
    • 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 » Afstyla (Antihemophilic Factor (Recombinant), Single Chain)

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

Afstyla (Antihemophilic Factor (Recombinant), Single Chain)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Afstyla (Antihemophilic Factor (Recombinant), Single Chain) is a recombinant, antihemophilic factor.

    Afstyla is specifically indicated for use in adults and children with hemophilia A (congenital Factor VIII deficiency) for:

    • On-demand treatment and control of bleeding episodes
    • Routine prophylaxis to reduce the frequency of bleeding episodes
    • Perioperative management of bleeding

    Afstyla is supplied as a powder and solvent for reconstitution for intravenous injection. Please see drug label for recommended reconstitution and dosing schedules for each indication.

    Clinical Results

    FDA Approval

    The FDA approval of Afstyla was based on on results from the AFFINITY clinical development program. AFFINITY includes two pivotal and one extension open-label multi-center studies evaluating the safety and efficacy of Afstyla in children, adolescents and adults with hemophilia A. The data from the AFFINITY clinical development program showed a median annualized spontaneous bleeding rate (AsBR) of 0.00 in both the adult and adolescent study as well as the pediatric study. The median annualized bleeding rate (ABR) was 1.14 in adult and adolescent patients and 3.69 in children less than 12 years of age using Afstyla prophylactically. Of 1,195 bleeds treated in the pivotal study (848 in adults and adolescents; 347 in children), 94 percent of bleeds in adult and adolescent patients and 96 percent of bleeding events in pediatric patients were effectively controlled with no more than two infusions of Afstyla weekly; 81 percent of bleeds in adult and adolescent patients and 86 percent of bleeding events in pediatric patients were effectively controlled by only one infusion. The majority of bleeding events treated with Afstyla (94 percent in adults and adolescents; 96 percent in children) were rated as excellent or good. Of the 13 adult or adolescent patients in the study who underwent surgical procedures (16 total surgeries), hemostatic efficacy of Afstyla was rated as excellent (15 times) or good (once).

    Side Effects

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

    • dizziness
    • hypersensitivity

    Mechanism of Action

    Afstyla (Antihemophilic Factor (Recombinant), Single Chain) is a recombinant, antihemophilic factor. Afstyla is a recombinant protein that replaces the missing Coagulation Factor VIII needed for effective hemostasis. Afstyla is a single polypeptide chain with a truncated B-domain that allows for a covalent bridge to link the Factor VIII heavy and light chains. Afstyla has demonstrated a higher VWF affinity relative to full-length rFVIII. VWF stabilizes Factor VIII and protects it from degradation. Activated Afstyla has an amino acid sequence identical to endogenous FVIIIa.

    Additional Information

    For additional information regarding Afstyla or hemophilia A, please visit http://www.afstyla.com/prescribing-information

    Approval Date: 2016-05-01
    Company Name: CSL Behring
    Back to Listings

    Upcoming Events

    • 15Sep

      Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

    • 21Sep

      The FDA’s Focus on Clinical Data Integrity Throughout Product Development and Approval

    • 16Oct

      WCG MAGI's Clinical Research Conference 2022 West

    • 16Nov

      17th Annual FDA Inspections Summit

    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

    • Options-360x240.png

      Cancer Patients Signal Interest in Less Travel, More Remote Trial Options

    • SurveywBlueBackground-360x240.png

      New Study Shows Trends in Funding, Racial Balance Amidst COVID-19

    • Complexity-360x240.png

      Rising Trial Complexities Create More Payment Problems, Frustrations for Sites

    • Challenge-360x240.png

      BYOD Trials Growing in Popularity, But Unique Tech Challenges Remain

    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 My Personal Information

    Footer Logo

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

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing