Biogen Updates Tysabri Label To Reflect Risk With Longer Use
By Thomas Gryta, Of DOW JONES NEWSWIRES
NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) amended the U.S. label of
multiple sclerosis treatment Tysabri, sold with Elan Corp. PLC (ELN), on Friday
to reflect that the risk of a rare brain infection rises with longer usage.
The changes, which were expected, note that the occurrence of progressive
multifocal leukoencephalopathy, or PML, in patients treated for 24 to 36 months
is "generally similar" to the 1-in-1,000 rate seen in clinical trials. The
changes warn that there is limited experience with the drug beyond three years
of treatment.
Lazard Capital Markets' analyst Joel Sendek said the changes appeared to be
benign.
"We do not expect physicians to significantly change their Tysabri prescribing
habits in the near-term," Sendek said in a research note. He continues to
project 2010 Tysabri sales of $1.1 billion.
Biogen had previous said it was discussing a label change with the Food and
Drug Administration to include duration-related risk, but some on Wall Street
had feared it would include suggestion for duration limits, or taking a "
holiday" from treatment.
Barclays Capital analyst Jim Birchenough wrote Friday that he believes the new
label will ultimately slow sales growth of the drug.
Biogen shares closed up 3.1% to $45.76 Friday, while Elan rose 6.2% to $6.58.
Aside from duration information, the updated label includes details on using
plasma-exchange therapy, which removes large molecules from the body's blood
circulation, thereby accelerating removal of Tysabri and theoretically improving
the immune response to PML infection.
It also explains that inflammation of the rebuilding of the immune system can
occur following discontinuation of Tysabri in patients with PML.
The label update comes after 24 cases of PML, including four deaths, have been
confirmed in Tysabri patients since it was removed from the market for 18 months
beginning in 2005 because of a link to PML, including two other deaths.
The drug, allowed back on the market after patients and physicians pushed for
its return, is key to the growth of both Biogen and Elan. It produces nearly $1
billion in yearly revenue.
The European agency's Committee for Medicinal Products for Human Use, known as
CHMP, has started a review of Tysabri because of the PML cases.
Despite the PML risk, Tysabri is widely seen as one of the most effective MS
treatments on the market, especially for those with severe cases who have few
other options, and it is consistently defended by the MS community.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com
(END) Dow Jones Newswires
11-06-091753ET
Copyright (c) 2009 Dow Jones & Company, Inc.
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