Drug makers update effort to reinstate Tysabri

Share this article:
Biogen Idec and Elan said that their efforts to reinstate multiple sclerosis drug Tysabri may turn a corner shortly.
The companies said their safety review of Tysabri (natalizumab) in Crohn's disease and rheumatoid arthritis should be completed "in the coming weeks," following which they plan on submitting a supplemental Biologics License Application to the FDA for the drug in MS.
A safety evaluation of Tysabri in MS, completed in August, resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML).
As first reported in the Associated Press, Biogen Idec CEO James Mullen said he would recommend that Tysabri's label carry warnings about three previously reported cases of PML, discovered after clinical trials, and a warning that patients with weak immune systems are more susceptible to it.
The three cases of PML, two of which were fatal, led Biogen Idec and Elan to withdraw Tysabri from the U.S. market in February and suspend clinical trials of the drug. Scientists still don't fully understand how Tysabri may have enhanced those patients' risk for contracting the rare demyelinating disease of the central nervous system.
Share this article:

Email Newsletters

More in News

In sunny world of LASIK marketers, a dark underbelly

In sunny world of LASIK marketers, a dark ...

Last week, the former FDA branch chief who originally approved LASIK machines asked FDA to reconsider its denial last month of his petition to ban these devices.

BMS Q2 sales slip, Eliquis, Yervoy soar

BMS Q2 sales slip, Eliquis, Yervoy soar

The company attributed part of the Eliquis boost to the BMS-Pfizer DTC and education efforts.

Gilead, Merck HCV marketing battle may be on horizon

Gilead, Merck HCV marketing battle may be on ...

Disclosed in its earnings report yesterday, Gilead may have a card up its sleeve to counter Merck's experimental hep. C combo regimen.