Idenix Pharmaceuticals (IDIX)

[DewDiligence]

Re: Baraclude label

In conjunction with a change to the Baraclude label relating to cross-resistance in HBV-HIV co-infected patients (#msg-17360663), Baraclude received a minor FDA label expansion on 2/23/07. The original (2005) FDA label said this:

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BARACLUDE (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. This indication is based on histologic, virologic, biochemical, and serologic responses after one year of treatment in nucleoside-treatment-naive and lamivudine-resistant adult patients with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease and on more limited data in adult patients with HIV/HBV co-infection who have received prior lamivudine therapy [emphasis added].
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The new Baraclude label removes the phrase “after one year of treatment”; the change is presumably based on BMY’s two- and three-year results that were presented at AASLD (#msg-14400271).

The new Baraclude label can be accessed at:
http://www.fda.gov/cder/foi/label/2007/021797s001,021798s001lbl.pdf
(The changed language is on page 11.)

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Tyzeka has an FDA label that is identical to the 2005 Baraclude label: i.e. it includes the “one year” qualifier. This could give BMY’s sales reps something to tout until NVS and IDIX get the “one year” language removed from the Tyzeka label. Based on the two-year Tyzeka data from the GLOBE trial presented at AASLD (#msg-14377860), this ought to be doable.