Merck Sharpe and Dohme to receive accelerated review of boceprevir
7 January 2011 00:00 in Pharmaceutical Company Product News
Merck Sharpe and Dohme has been granted expedited review status from EU regulators for its new hepatitis C treatment boceprevir.
The European Medicines Agency has agreed to conduct an accelerated assessment of the company's marketing authorisation application for the drug, based on its potential ability to address unmet medical needs.
This designation has been granted on the back of clinical data submitted by Merck Sharpe and Dohme, which illustrates the drug's efficacy when combined with standard therapy in assisting adult patients with compensated liver disease.
In addition, the US Food and Drug Administration has elected to grant boceprevir its equivalent priority review status for the same reasons.
Dr Peter Kim, president of Merck Research Laboratories, said: "Our goal is to be able to bring forward a new treatment option for patients living with chronic hepatitis C and we are now closer to that goal."
Last month, Merck Sharpe and Dohme agreed a deal to research a malaria vaccine in partnership with the PATH Malaria Vaccine Initiative and NYU Langone Medical Center.
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