Biogen/Elan pull Tysabri after patient death

The companies are voluntarily suspending supply of Tysabri from commercial distribution and have requested that physicians stop prescribing the treatment. In addition, the companies have suspended dosing in all clinical trials.

This industry-shocking decision is based on recent reports of two serious adverse events that have occurred in multiple sclerosis (MS) patients treated with Tysabri in combination with Avonex in clinical trials. These events involve one fatal, confirmed case and one suspected case of progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of the central nervous system. Both patients received more than two years of Tysabri therapy in combination with Avonex.

MS patients’ reactions to the withdrawal have, according to reports, shown more of a concern with not being able to access the treatment than with safety risk concerns. Tsyabri has proved popular with many MS patients, who have embraced it as a potential breakthrough since its launch just months ago.

In contrast, Tsyabri’s suspension has boosted Teva, which makes rival product Copaxone, sending its shares on the Tel Aviv Stock Exchange soaring after the surprise announcement. Meanwhile, both Biogen Idec and Elan Corporation’s shares have recovered since the announcement was first made and it is even rumored that Tysabri could be back on the market this year.

Biogen Idec and Elan Corporation will now work with clinical investigators to evaluate Tysabri-treated patients and will consult with leading experts to better understand the possible risk of PML. The outcome of these evaluations will be used to determine possible re-initiation of dosing in clinical trials and future commercial availability.