Genzyme Plant Approved to Begin Manufacture of Drug in Critically Short Supply - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Genzyme Plant Approved to Begin Manufacture of Drug in Critically Short Supply


ePT--the Electronic Newsletter of Pharmaceutical Technology

Genzyme, a unit of Sanofi, announced in a press release that FDA had approved its manufacturing facility in Framingham, Massachusetts, for production of Fabrazyme (agalsidase beta). Fabrazyme is used in the treatment of Fabry’s disease, a rare genetic disorder for which it is the only FDA-approved treatment. The company announced EMA approval for the plant on Jan. 18, 2012.

According to the press release, the company expects all patients in the US currently on therapy to be returned to full dosing beginning in March. Globally, the company expects a complete return to normal supply levels of Fabrazyme to begin in the second quarter and continue throughout the year. Genzyme will begin the process of moving the most severely affected patients in Europe to full doses of Fabrazyme in the first quarter of 2012.

Shortages of Fabrazyme have been ongoing for the past two years. Problems began in 2009 with GMP deficiencies found during an inspection of its Allston, Massachusetts, plant that culminated in a consent decree in May of 2010. Since that time, Fabrazyme has been in short supply, leading to rationing of the drug and frustration among patients.

Genzyme’s President and CEO David Meeker said in the release, “We are very pleased with the FDA approval of our Framingham plant as we continue our manufacturing recovery and path forward to serve the Fabry patient community. With this approval, we continue upon our 2012 plan to restore unconstrained supply for all patients globally throughout the course of the year.”

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here