) recently announced that Health Canada has approved a change in
the label of its multiple sclerosis (MS) drug, Tysabri. The new
label of the drug indicates anti-JC virus (JCV) antibody status as
a risk factor for developing a rare, serious brain infection known
as progressive multifocal leukoencephalopathy (PML). Infection by
the JC virus leads to the development of PML.
This is the third risk factor identified by Biogen for MS
patients on treatment with Tysabri. It helps assess the
benefit-risk profile of the drug, ensuring that physicians and
patients make more informed choices in treating a debilitating
disease like MS. Patients who are anti-JCV antibody positive, have
received prior immunosuppressant therapy and have been treated with
Tysabri for more than two years are most likely to develop PML.
Prior to the Canadian approval for the label update the U.S.
Food and Drug Administration and the European Commission had
approved anti-JCV antibody status as a means of identifying
patients at a higher risk of contracting PML. Biogen said that
59,000 anti-JCV antibody tests were conducted through the third
quarter of 2011.
Tysabri recorded global sales of $1.5 billion in 2011. Tysabri
is approved in more than 65 countries and faces stiff competition
Teva Pharmaceutical Industries Limited's
)/Serono's Rebif and
) Extavia. Tysabri is facing additional competition in the form of
Novartis' Gilenya, which was launched in early Oct 2010.
The updated label should help increase awareness about the
antibody status of both existing as well as prospective
With the updated label, Biogen should be in a position to
approach neurologists and provide the MS community with more
confidence when considering treatment options.
We currently have a Neutral recommendation on Biogen in the long
run. Biogen carries a Zacks #3 Rank (Hold rating) in the short
BIOGEN IDEC INC (BIIB): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
TEVA PHARM ADR (TEVA): Free Stock Analysis
To read this article on Zacks.com click here.