An end to the Farbrazyme shortage?

Sanofi's Genzyme Corp. starts shipping Fabrazyme from new plant
| 2 min read
Register for free to listen to this article
Listen with Speechify
0:00
2:00
CAMBRIDGE, Mass.—Since 2009, when a virus was discovered  in its manufacturing plant in Allston, Mass., Genzyme Corp. has take a lot of heat for shortages of the drug Fabrazyme to treat the rare genetic disorder, Fabry disease. This led to patients having to sharply reduce their dosages and even skip taking it at times. Now, however, there may be a light at the end of the tunnel, as the company, now owned by Sanofi, announced March 2 that it hasbegun shipping Fabrazyme produced at its newlyapproved plant in Framingham, Mass.
 
According to Genzyme,all patients in the United States can return to full dosing this month. Inaddition, all newly diagnosed patients in the United States are eligible to begin Fabrazymetreatment at full dosing levels.
 
"The ability to meet the needs of patients in the U.S. is an importantfirst step in restoring unconstrained supply for all patients globallythroughout the course of 2012," said Genzyme's president and CEO DavidMeeker.
 
In Europe, the process of moving the most severely affected patients tofull doses of Fabrazyme will begin this month. Globally, the completereturn to normal supply levels of Fabrazyme will begin in the secondquarter and continue throughout the year, as Genzyme works toobtain all global regulatory approvals throughout the year and to buildinventory.
 
The Food and Drug Administration (FDA) and the European Medicines Agency(EMA) approved the manufacturing plant in Framingham, Mass., for theproduction of Fabrazyme in January 2012.
 
Fabrazyme is approved for treatment of Fabry disease, an inheritedcondition that is characterized by excessive accumulation of the lipidGL-3 in various organs and tissues, which over time can cause renal,cardiac and cerebrovascular events. As a result, patients with Fabrydisease typically have a shortened life span, and children must oftencope with significant pain and disability. Fabry disease is an inheritedand life threatening disease linked to the X chromosome which affectsapproximately 5,000 patients in the world.
 

About the Author

Related Topics

Loading Next Article...
Loading Next Article...
Subscribe to Newsletter

Subscribe to our eNewsletters

Stay connected with all of the latest from Drug Discovery News.

Subscribe

Sponsored

Close-up illustration of clustered, irregularly shaped 3D cell structures resembling organoids, displayed in a blue-toned background.
Machine learning-powered image analysis makes it possible to automatically and reliably quantify complex 3D cell structures.
Illustration of a glowing human brain with interconnected neural networks and bright data points, set against a dark, digital background.
Take a closer look at modern techniques that reveal when, where, and how neurons communicate in real time.
Gloved hand holding a petri dish containing red liquid culture medium against a light blue background.
As global regulations shift toward animal-free testing, how can researchers develop more biologically relevant in vitro models to advance drug discovery?
Drug Discovery News June 2025 Issue
Latest IssueVolume 21 • Issue 2 • June 2025

June 2025

June 2025 Issue

Explore this issue