Roche Holding AG
) recently announced that the European Medicines Agency (EMA) has
approved a label expansion for Pegasys in combination with
ribavirin for the treatment of chronic hepatitis C virus (HCV) in
children and adolescent five years and older.
We note that Pegasys plus antiviral ribavirin is approved for
the treatment of chronic HCV, human immunodeficiency virus
(HIV)/HCV co-infection and chronic hepatitis B in adults.
Children and adolescents aged five years or more who have not
received prior treatment and have been tested positive can now be
treated with Pegasys plus ribavirin. Roche had conducted a
randomized controlled study based on which approval was
The study results revealed that a larger percentage of
children treated with the Pegasys plus ribavirin combination
achieved sustained viral response than the children treated with
Pegasys alone (53% versus 21%). The results in children and
adolescents were similar to the results observed in adults
infected with HCV genotype I.
We note that companies like
Merck & Co. Inc.
Vertex Pharmaceuticals Inc.
) have a presence in the HCV market.
The label expansion on Pegasys into the children and
adolescent population is a positive. Recently, Roche received US
Food and Drug Administration (FDA) approval for a next-generation
viral load test for use in chronic HCV patients. We are pleased
with Roche's progress in the treatment of HCV.
Roche currently carries a Zacks Rank #4 (Sell). Stocks which
currently look well-positioned include
). Novo Nordisk carries a Zacks Rank #2 (Buy).
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