We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Teva Pharmaceuticals’ Parkinson’s Drug Azilect Gains New FDA Indication

Teva Pharmaceuticals’ Parkinson’s Drug Azilect Gains New FDA Indication

June 10, 2014

Teva Pharmaceutical Industries announced Monday that the FDA has expanded the indication for its Parkinson’s disease drug Azilect (rasagiline tablets), from monotherapy and adjunct to levodopa (LD) to now include adjunct to dopamine agonists (DAs).

The new indication means that Azilect can be used to treat all stages of Parkinson’s disease (PD), either alone or in combination with other PD medications, the Israel-based drugmaker said.

The FDA’s approval was based on a supplemental new drug application submitted by Teva, supported by clinical evidence from the ANDANTE study (Add oN to Dopamine AgoNists in the TrEatment of Parkinson's disease), the company noted.

Teva said study demonstrated that Azilect delivers a clinical benefit by greatly improving total Unified Parkinson's Disease Rating Scale (UPDRS) scores, while demonstrating tolerability. The drug was compared to placebo in patients on DA monotherapy.

"Azilect has been well studied and has been shown to be safe and effective as monotherapy in early PD and as an adjunct to LD in moderate-to-advanced PD. The ANDANTE study provides evidence that Azilect is also effective as an adjunct to dopamine agonist therapy," said Robert A. Hauser, professor of Neurology, Molecular Pharmacology and Physiology at the University of South Florida.

"The expanded AZILECT indication supports the concept of adding AZILECT to DA monotherapy to improve symptoms while offering another treatment option prior to either increasing the dose of DA monotherapy or initiating LD,” Hauser added. — Kellen Owings

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.

Pharmaceuticals Submissions and Approvals

Upcoming Events

  • 13Jul

    FDA Ad and Promo Enforcement Trends: Past, Present and Future

  • 27Jul

    Applying the Lessons of the Pandemic to Your Upcoming Trial

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

  • 02Aug

    Medical Device Cybersecurity: Understand the Latest Developments

  • 03Aug

    Pharmaceutical Process Validation: Best Practices for Success

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • FX Receives FDA Clearance for Its FX V135 Shoulder Arthroplasty Platform

  • FDA Recommends Modified COVID-19 Vaccine Boosters Adapted to Omicron BA.4 and BA.5 Subvariants

  • FDA Approves Foundation Medicine’s Companion Diagnostic for Genentech’s Rozlytrek

  • Novartis Pays $100 Million for Mallinckrodt’s Priority Review Voucher

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

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