03.01.12
Genzyme has begun shipping Fabrazyme (agalsidase beta) produced at its newly approved plant in Framingham, MA, allowing U.S. patients to return to full dosing in March. Also, new patients in the U.S. are eligible to begin Fabrazyme at full dosing levels. The FDA and the EMA approved the Framingham plant for the production of Fabrazyme in January 2012, and it is intended to alleviate shortages caused by the shutdown of Genzyme’s Allston, MA facility, which suffered from quality issues.
In Europe, the most severely affected patients will return to full dose of Fabrazyme beginning in March. Globally, the complete return to normal supply levels will begin in the second quarter and continue throughout the year.
“The ability to meet the needs of patients in the U.S. is an important first step in restoring unconstrained supply for all patients globally throughout the course of 2012,” said Genzyme’s president and chief executive officer, David Meeker.
In Europe, the most severely affected patients will return to full dose of Fabrazyme beginning in March. Globally, the complete return to normal supply levels will begin in the second quarter and continue throughout the year.
“The ability to meet the needs of patients in the U.S. is an important first step in restoring unconstrained supply for all patients globally throughout the course of 2012,” said Genzyme’s president and chief executive officer, David Meeker.