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The U.S. Food and Drug Administration has decided to add new safety information to the label for the multiple sclerosis drug, Tysabri, which is co-owned by Biogen Idec.
The change is related to the incidence of a rare neurological infection known as PML (progressive multifocal leukoencephalopathy). The FDA is adding to the “Warnings and Precautions” section of the label to indicate that the risk of PML increases with longer use of the therapy. The new label also notes risk of a condition known as IRIS (Immune Reconstitution Inflammatory Syndrome), which can occur after patients discontinue Tysabri treatment due to PML infection.
Officials at the Cambridge biotechnology company have previously disclosed that the risk of PML increases with the duration of treatment and have said that the overall incidence of PML is still within the range that is indicated on the label, which is one case per 1,000 patients taking the drug.
However, the incidence of PML increases to a total of 1.8 per 1,000 patients for those patients outside the U.S. receiving more than 30 Tysabri infusions, according to the FDA.
Biogen officials have said they believe the incidence of PML is higher outside the U.S. in part because many of those patients have taken more therapies prior to Tysabri treatment.
There have been 31 confirmed cases of PML since Tysabri was re-launched in July of 2006. Eight of those cases have been fatal. The drug was briefly taken off the market due to concerns about the infection, between 2005 and 2006.
In its letter advising health-care professionals of the new warning, the FDA reiterated its belief that the clinical benefits of Tysabri outweigh the risks. Biogen spokeswoman Naomi Aoki said that the company has already updated the label to reflect these changes, following discussions with the FDA in the fall.
Biogen and co-owner Elan Pharmaceuticals announced last month that Tysabri had hit the benchmark of a bonafide blockbuster — $1 billion in annual sales for 2009.
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