• 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
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Pfizer receives kosher certification for Elelyso for injection

Pfizer receives kosher certification for Elelyso for injection

May 19, 2014
CenterWatch Staff

Pfizer has announced that the Orthodox Union (OU) has granted kosher certification to ELELYSO (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is the first prescription medication to be certified kosher by the OU, a milestone for the brand which was approved by the FDA in May 2012. 

"Type 1 Gaucher disease is a rare disease, most frequently found among individuals of Ashkenazi Jewish descent, which has a significant impact on patients and their families," said Rory O'Connor, Pfizer's senior vice president, head of Global Medical Affairs, Innovative Pharma Business.

ELELYSO is an FDA-approved plant-based treatment option for type 1 adult Gaucher patients that, in addition, meets the stringent standards of kosher regulation and inspections. The OU, the most recognized certifier of kosher products worldwide, inspected the Protalix Biotherapeutics manufacturing facility in Israel in which ELELYSO is produced to ensure that the treatment met all applicable qualifications. The criteria were met due to Protalix's innovative and proprietary manufacturing system, which uses genetically engineered carrot cells grown in a simple solution of water, plant extracts, sugar and a mixture of vitamins and minerals to produce ELELYSO. 

"We are proud to grant kosher certification to ELELYSO. Gaucher disease and its treatment options are an important issue in the Jewish community, as one in 14 Ashkenazi Jews are carriers for the disease compared to the general population," said Rabbi Menachem Genack, CEO of OU Kosher. "In a life or death situation, Jewish law clearly sets aside the kosher status of a prescription medicine, but in other cases, it is preferable and sometimes recommended that a medicine be certified kosher. We commend Pfizer for taking this step and making this commitment to the Jewish community." 

Protalix is the first Israeli biotech firm to partner with Pfizer. ELELYSO is the first FDA-approved plant cell-based recombinant therapeutic protein. 

Upcoming Events

  • 23Mar

    Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • MachineLearning-360x240.png

    Industry Using AI/ML to Improve Data, Quality and Trial Management, Survey Says

  • VirtualTraining-360x240.png

    Virtual Training Evolves into More In-Depth Learning, Improved Communications

  • SurveywBlueBackground-360x240.png

    Mid-Study Updates Delay Trials At Least a Month, CSDD Report Finds

  • Real-TimeData-360x240.png

    Real-Time Data Helped Sponsors Respond to Sites’ Needs During the Pandemic

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 © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing