ELN, BIIB dismiss Tysabri report

Elan (ELN) and Biogen Idec (BIIB) dismissed a report from Morgan Stanley analyst Steven Harr that said Tysabri natalizumab could be linked to new side effects. Harr said more than 300 Tysabri adverse events were reported to FDA's Adverse Event Reporting System (AERS), including 15 deaths -- among them the two known deaths from progressive multifocal leukoencephalopathy (PML). Harr's report said other deaths that could be related to Tysabri include two patients with signs of opportunistic infection and five with signs of sepsis. According to the analyst, the remaining six deaths were probably not related to the drug.

BIIB spokesperson Amy Brockelman said the safety evaluation that BIIB and ELN reported earlier this month revealed no new safety signals, infectious or otherwise. ELN spokesperson Davia Temin added that the safety evaluation, which included multiple sclerosis (MS) patients who were given Tysabri in clinical trials, reflects the most up-to-date Tysabri safety data. Ongoing safety evaluations in about 1,500 patients with Crohn's disease and rheumatoid arthritis (RA) are expected to be completed by the end of the summer. ...