Biogen Idec (BIIB) and partner Elan Corporation (ELN) recently announced that the action date for their supplemental Biologics License Application (sBLA) for Tysabri has been extended by the US Food and Drug Administration (FDA).
The companies had submitted the sBLA in December 2010. Biogen and Elan are looking to update Tysabri’s prescribing information so as to include anti-JC Virus antibody status as a factor that could help stratify the risk of progressive multifocal leukoencephalopathy (PML) occurring in patients treated with Tysabri.
The FDA has extended the review period by three months, which means a response should be out in early 2012. The agency said that it needs the additional time to review the changes being incorporated into the Risk Evaluation and Mitigation Strategies (REMS) program for Tysabri.
We note that the EU label of Tysabri has already been modified so as to include anti-JC Virus antibody status as a potential factor that could help stratify the risk of PML occurring in patients treated with Tysabri.
Tysabri, which is approved in more than 60 countries, is administered as a single intravenous infusion every four weeks. Tysabri, initially approved in 2004, was withdrawn from US markets in 2005 due to the PML concern. The drug was reintroduced by Biogen and Elan after a year with a strict warning regarding the occurrence of PML, a rare but serious brain infection.
The prescribing information on Tysabri’s label includes information regarding the increased risk of developing PML increases with longer use of the drug. The label also includes language regarding limited experience beyond 3 years of treatment.
Despite carrying a black box warning for the risk of PML and other cautionary language, Tysabri posted $1.2 billion in sales in 2010. Biogen has been conducting studies (STRATIFY 1 and STRATIFY 2) to confirm that patients who test negative on the JC virus assay can use Tysabri with lower concerns regarding the development of PML.
We currently have a Neutral recommendation on Biogen, which carries a Zacks #3 Rank (short-term Hold rating).
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