Genzyme is pulling 9 lots of its kidney transplant drug Thymoglobulin after one lot failed a stability test. The company, which is Sanofi's ($SNY) U.S.-based rare disease division, pulled all lots made with raw material suspected to be the "root cause" of the potential shelf-life issue.
FDA says Genzyme hasn't identified any new safety risks for patients who've been treated with the now-recalled product, and that it knows of no "confirmed safety issues directly associated" with stability failure. Thymoglobulin brought in more than $250 million in worldwide sales last year, according to EvaluatePharma.
Genzyme has recalled Thymoglobulin for stability problems before. In 2008, the company pulled one lot after samples didn't pass a visual examination. That was before the company was forced to shut down manufacturing of several rare-disease drugs, because of viral contamination at a Boston-area plant.
Sanofi bought Genzyme last year for its expertise in rare diseases, a fast-growing pharma niche. At the time, Genzyme was still struggling with supply problems stemming from that 2009 contamination problem. The company won FDA approval for its Framingham, MA, plant early this year, and began shipping Fabrazyme from there in March.
- read the FDA recall notice
- see the Reuters news
Like what you're reading