Biogen Idec is going to start providing updates on Tysabri and new cases of the often-fatal brain infection, progressive multifocal leukoencephalopathy, or PML.
Biogen Idec Inc. had stopped providing the monthly PML updates last summer. But in September, the U.S. Food & Drug Administration (FDA) revealed that 24 cases of PML had been reported in Tysabri users, more than double the 11 Biogen Idec had disclosed at its final monthly update in July. As of mid-January, the number of PML cases among people treated with Tysabri stands at 31.
According to The Wall Street Journal, through the new Tysabri monitoring program, Biogen Idec will update physicians about new PML cases at the middle of each month. Doctors will be able to access this information through a password-protected Web site. In addition to the number of PML cases, Biogen Idec will provide details on duration of use, as well as a cumulative patient exposure figure. Investors will be able to access the same information via Investor Relations.
According to the Journal, no public Web site will be launched to provide the information. Tysabri patients can request the information, but the information they will be provided will not be as detailed as what doctors, or even investors, are give. The disparity is the result of regulations that restrict direct interactions between patients and drug companies.
In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical trials developed PML. But the drug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing MS or Crohn’s Disease who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections.
