Yet again, the multiple-sclerosis medication has caused a serious brain infection, the same malady that prompted the drug to be withdrawn in 2005 for about a year. A German MS patient contracted PML, or progressive multifocal leukoencephalopthy, and remains hospitalized, according to afiling by Biogen with the Securities and Exchange Commission.
This is not good news for Biogen and its marketing partner, Elan, which have issued three previous statements this year about four other MS patients contracting PML after taking Tysabri (back story). Nonetheless, the drug has been used by about 35,500 patients as of September, and about 9,500 have taken the injection for at least 18 months, The Wall Street Journal notes.
Coincidentally, the disclosure comes just a few days after Novartis reported that an experimental MS pill cut annualized relapse rates by 38 to 52 percent in a study, depending on the dose, compared with treatment with Avonex, another Biogen MS drug. Moreover, one investor just called for the ouster of the Elan ceo over complaints that Tysabri marketing was botched (see here).