Genzyme has fallen short on shipments again. Now the U.S. unit of France's Sanofi, the company did not distribute its Fabry disease drug in August, after promising patients in July that Fabrazyme would be forthcoming. In an apologetic letter to patients, released by the FDA, Genzyme blamed the lack of Fabrazyme supply on an "unexpected delay related to our quality release process."
The August disappointment comes after two years of Fabrazyme scarcity. Since Genzyme's Boston-area plant was contaminated by a virus in 2009, the company has been struggling to fix its manufacturing problems and supply its rare-disease drugs to patients who often had no other treatment options. Genzyme's supply of Cerezyme, a drug for Gaucher disease, finally hit full strength earlier this year, but Fabrazyme production has continued to lag.
The company worked closely with Fabry disease patients on a rationing scheme that involved skipping doses. The August delays involved some scrambling on Genzyme's part, as the company worked to notify patients to cancel their scheduled infusions. "We realize that this delay has made it difficult to plan for infusions and has been confusing and inconvenient for both patients and healthcare providers," the company said in its letter.
Genzyme told patients that it "anticipates" being able to ship the August supply for patients this month. It also said it expects to ship an additional allocation of the drug for September. An update on that planned shipment will be issued in mid-September. But Genzyme hedged a bit on that schedule, saying it still can't say exactly when Fabrazyme will be shipped. One bright spot on the horizon: The company's new plant in Framingham, MA, which awaits FDA approval. That will give Genzyme lots more capacity. Till then, however, Fabrazyme's supply woes could well continue.
- see the news from Reuters
- get the Genzyme letter at FDA