* Genzyme apologized for Fabrazyme shipment delay
* August doses to be shipped in September
WASHINGTON, Sept 7 (Reuters) - Genzyme, the U.S. biotech unit of French drugmaker Sanofi SA (SASY.PA), failed to ship rare disease drug Fabrazyme in August despite telling doctors and patients the shipment would be prompt.
U.S. drug regulators made public on Wednesday letters from Genzyme dated Aug. 25 and 26 in which the company apologized to healthcare providers and Fabry disease sufferers for “any confusion and disruption” caused by the delay. The regulators also released letters dated July 25 and 26 promising to ship the August allocations on time.
“At the time of that (July) communication, all indications were that we would be able to ship Fabrazyme promptly,” Genzyme said in the letters posted on the Food and Drug Administration website. “However, shortly after that communication we experienced an unexpected delay related to our quality release process and were not able to ship Fabrazyme as expected.”
The company said it expected to ship the August allocation for patients taking the drug, but not until September. Genzyme also expected to ship this month’s allocation and would issue an update on the shipment’s status in mid-September.
Fabrazyme is used to treat Fabry disease, a rare inherited disorder that affects about 5,000 to 10,000 people worldwide. Genzyme has been working to recover from severe shortages of the drug caused by a viral plant contamination in 2009.
To read Genzyme's letter, see r.reuters.com/xaj63s. (Reporting by Alina Selyukh; editing by Andre Grenon)