Genzyme is advising U.S. doctors to prepare for a mid-April to mid-June shortage of Thyrogen. And the European Medicines Agency says Genzyme Europe BV has warned the thyroid cancer treatment will be in short supply until July.
The EMA says Genzyme will meet approximately 45 percent of EU demand in the interim. Global supply is expected to fluctuate through July, according to the Boston Globe.
The shortage is being attributed to "a manufacturing issue" by the EMA. A Genzyme announcement says the drugmaker "continues to work toward obtaining regulatory approvals worldwide for the fill/finish transfer to a third-party contract manufacturing facility."
Revalidation of fill/finish equipment caused a delay last fall in Thyrogen shipping. At that time, fill/finish was the only part of Thyrogen production taking place at Genzyme's Allston Landing site, now operating under consent decree with the FDA. Genzyme was then in the process of moving the fill/finish operations out of the Boston area site in accordance with the decree.