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US regulators approve first targeted hepatitis C drug

logo2c.gifThe US Food and Drug Administration has approved Victrelis (boceprevir), the first drug to directly target the hepatitis C virus (HCV). The drug, made by New Jersey-based Merck, targets an HCV protein called the NS3 protease, which is critical for proper processing of the virus’s proteins.

Another drug that targets NS3 – Incivek (telaprevir) which is made by Vertex Pharmaceuticals in Cambridge, Massachusetts – is expected to be approved by 23 May. Both drugs received unanimous support from regulatory advisers in April.

The approvals mark a new era in HCV treatment which until now has been limited to broad-spectrum antiviral drugs, such as interferon, with poor efficacy and unpleasant side effects. Other directed therapies are making their way through the pipeline (for more, see ’New drug targets raise hopes for hepatitis C cure’).

Telaprevir has a slight efficacy advantage over boceprevir, and analysts at the Boston-based investment bank Leerink Swann expect boceprevir to capture only about 20-30% of the market. Leerink projects global telaprevir sales to reach $5.2 billion in 2013.

UPDATE: On 23 May, the US Food and Drug Administration announced the approval of Incivek (telaprevir).

Comments

  1. Report this comment

    J. Annonce said:

    This seems to be great news, and we know how FDA can be tough when approving drugs.

    However, I wonder when will this new drug be available in Europe… Any idea?

    We cruelly lack that kind of medical solutions and this could be a real hope our patients there.

    Regards,

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