Psoriasis drug Raptiva tied to serious brain infection

California, February 20: Raptiva, the established Psoriasis drug manufactured by Genentech Inc., California-based leading biotechnology corporation, strongly links to progressive multifocal leukoencephalopathy (PML), a rare brain infection, U.S. Food and Drug Administration confirms.

In a public health advisory issued on Thursday, FDA confirmed the PML- Raptiva link in four patients. Three of those patients have died.

All four patients were being treated with the drug for more than three years. In addition, none of the patients was receiving any other immunosuppressant, a drug that suppresses the immune systemdefine, the FDA revealed.

PML is a rare and usually fatal viral disease. Typically afflicting people with severe immune deficiency, the disorder is characterized by progressive damage or inflammation of the white matter of the brain. Classic symptoms include extreme weakness, loss of coordination, impaired vision and speech and cognitive deterioration. The infection usually leads to death or severe disability.

Raptiva, administered as a once-weekly jab is approved to treat moderate to severe forms of psoriasis, an autoimmune skin disorder, which affects the skin and joints.

Typically characterized by the appearance of red scaly patches, inflammation and excessive skin production, the condition afflicts an estimated 7.5 million Americans. Its severity ranges from mild (affecting less than 3 percent of the body), to moderate (affecting 3-10 percent of the body) to severe (complete body coverage).

The drug already carries a black box warning, the sternest alert possible, implying that the drug carries a significant risk of serious or even life-threatening adverse effects.

Ironically, its labels already encrypted an increased risk of opportunistic infections including bacterial sepsis (a blood infection that affects other body organs), viral meningitis (a brain infection), invasive fungal disease and PML.

The drug label also included data from juvenile animal studies in mice that illustrated a potential risk for permanent suppression of the immune system with repeated administration of Raptiva drug. The age of juvenile mice was equivalent to children up to 14 years old and thus Raptiva was not approved for children less than 18 years of age.

While the FDA is still reviewing the new information and might just impose ‘sales suspension’, Genentech ensures that it is taking "the risk of PML very seriously and are working diligently with the FDA to put the right plans in place that will help protect patient safety."

"We are evaluating all possible approaches to address the risk of PML with Raptiva use, including a risk minimization plan" Tara Cooper, company’s spokeswoman said.