Efalizumab
| Monoclonal antibody | |
|---|---|
| Type | ? |
| Source | Human |
| Target | CD11a |
| Clinical data | |
| ATC code | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
Efalizumab (trade name Raptiva, Genentech, Merck Serono) is a medication designed to treat psoriasis. As its name implies, it is a recombinant humanized monoclonal antibody that binds to CD11a and acts as an immunosuppressant. It is administered once weekly by subcutaneous injection. It acts to inhibit white blood cell migration out of blood vessels into tissues. Because it suppresses the immune system, it has been associated with fatal brain infections, and has been withdrawn from the market.
Known side effects include bacterial sepsis, viral meningitis, invasive fungal disease and progressive multifocal leukoencephalopathy, a brain infection caused by reactivation of latent JC virus infection. [1]
Due partly to the risks of PML, the European Medicines Agency recommended in February 2009 that efalizumab be suspended from sales in the European Union, deeming that its benefits no longer outweighed its risks. [2]
On April 8, 2009, Genentech Inc. said it plans a phased voluntary withdrawal of Raptiva from the U.S. market.[3]
On March 13, the FDA approved safety labeling revisions for efalizumab subcutaneous injection (Raptiva; Genentech, Inc) to provide strengthened warnings regarding the risk for progressive multifocal leukoencephalopathy (PML) that has resulted in the product's withdrawal from the market as of June 8, 2009.
References
- ^ "Efalizumab FDA Warning". Retrieved 2008-12-7.
{{cite web}}: Check date values in:|accessdate=(help) - ^ "EMEA press release regarding suspension" (PDF). Retrieved 2009-02-20.
- ^ "Genentech Announces Voluntary Withdrawal of Raptiva from the U.S. Market" (Press release). Genentech, Inc. 2009-04-08. Retrieved April 9, 2009.
{{cite press release}}: Check date values in:|date=(help)
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