Genzyme lifted by EU approval of Fabrazyme facility
pharmafile | January 20, 2012 | News story | Manufacturing and Production |Â Â Boston, EMA, Fabrazyme, GenzymeÂ
Sanofi subsidiary Genzyme moved a crucial step closer to resolving its long-standing manufacturing problems after the European Medicines Agency gave a green light to its facility in Framingham, US.
The Framingham facility in Massachusetts has been approved by the EMA for the manufacture of Genzyme’s Fabry disease treatment Fabrazyme (agalsidase beta), which remains in short supply thanks to ongoing quality control issues at Genzyme’s Allston Landing plant near Boston.
Genzyme stressed that the return to normal supply levels of Fabrazyme ‘will not be immediate’, noting it will take some time to secure additional regulatory approvals for the Framingham plant and build up production.
Genzyme was forced to shut down the Allston Landing plant temporarily in 2009 after a contamination incident, leading to enforced rationing and dosage restrictions for Fabrazyme, and also patients on the company’s Gaucher drug Cerezyme (imiglucerase).
It has charted a difficult route back to full productivity, having to ditch a failed batch of Fabrazyme made at Allston Landing last March, and recently increased its timelines for bringing Cerezyme production back up to speed after seeing decrease in yields of the drug, and longer release times for batches.
The company now says its plan is to restore Fabrazyme levels to normal levels over the course of 2012.
“This approval by the EMA represents an important milestone in our manufacturing recovery and path toward unconstrained supply for all patients,” said David Meeker, who was appointed Genzyme’s president and chief exectuive in October.
Genzyme’s gain could represent a loss for rival drugmaker Shire, whose competing Fabry disease drug Replagal (agalsidase alfa) has been benefitting from the shortfall in Fabrazyme supplies.
Shire too has been held back by capacity constraints, however, and it has been racing to bring a facility in Lexington online to boost supplies. In November 2011 it filed for approval of the new facility with the US and EU regulatory authorities.
Phil Taylor
Related Content
Rethinking oncology trial endpoints with generalised pairwise comparisons
For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …
NICE issues positive final guidance for treatment of Duchenne Muscular Dystrophy from Santhera
Santhera Pharmaceuticals has received positive final guidance from the National Institute for Care and Excellence …
Eplontersen recommended for EU approval by CHMP for treatment of hereditary transthyretin-mediated amyloidosis
Wainzua (eplotersen), produced by AstraZeneca and Ionis, has been recommended for approval in the European …
