[4/8/2009] FDA has been informed by Genentech, Inc., the sponsor of Raptiva (efalizumab), of their decision to initiate a voluntary withdrawal of Raptiva. The voluntary withdrawal will occur in phases over the next several months. Genentech’s decision to withdraw is based on the finding of an association with the use of Raptiva and an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. Over the next several months, healthcare providers will be transitioning patients with psoriasis currently using Raptiva to alternate treatments. Healthcare providers are being asked to not initiate Raptiva treatment for any new patients.
FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market
FDA Public Health Advisory Updated Safety Information about Raptiva (efalizumab)[ARCHIVED]
- Raptiva Label (2009) (PDF - 746KB)
Raptiva (efalizumab) Feb 2009[ARCHIVED]