'Victrelis'(R) (boceprevir) Authorised In The European Union

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'Victrelis'® (boceprevir) Authorised In The European Union

22 Jul 2011

MSD (NYSE: MRK), known as Merck in the United States and Canada,

announced today that the European Medicines Agency (EMA) has granted

marketing authorisation to 'Victrelis'(boceprevir), the first

licensed product in a new class of medicines to treat hepatitis C.

Boceprevir is indicated to treat chronic hepatitis C (CHC) genotype

1 infection, in combination with peginterferon alfa and ribavirin,

in adult patients with compensated liver disease who are previously

untreated or who have failed previous therapy.

Boceprevir is the first direct acting antiviral agent targeting the

hepatitis C virus, to be licensed by the European Medicines Agency

(EMA). It works by interfering with viral replication by inhibiting

a key viral enzyme (NS3 serine protease). Boceprevir was authorised

using an accelerated assessment due to its major public-health

interest. It now has unified labelling, valid in the 27 European

Union (EU) member state countries, as well as European Economic Area

members, Iceland, Liechtenstein and Norway.

"We are delighted the EMA has granted marketing authorisation to

boceprevir in combination with current standard therapy," said

, Medical Director UK. "Boceprevir represents the first

licensed drug in a new class of medicines and the first drug to be

granted marketing authorisation for HCV treatment in 10 years. MSD

is proud to deliver innovative health solutions and provide a new

treatment option for patients with chronic hepatitis C genotype 1."

The EMA decision is based on the efficacy and safety results from

two large Phase III clinical studies conducted at EU and U.S. sites

that evaluated approximately 1,500 adult patients with chronic HCV

genotype 1 infection.1A,2A The HCV SPRINT-2 study involved 1,097

patients who were new to treatment ('treatment-naïve')1A and the HCV

RESPOND-2 study involved 403 patients who had failed previous

therapy.2A Final results of the studies were published in the New

England Journal of Medicine on March 31, 2011. Boceprevir, in

combination with standard of care, showed encouraging statistically

significant improvements in sustained virological responses or cure

rates compared to standard of care alone, with a manageable toxicity

and side effect profile.1B,2B

Notes

MSD's global commitment to advancing hepatitis therapy

MSD is committed to building on its strong legacy in the field of

viral hepatitis by continuing to discover, develop and deliver

vaccines and medicines to help prevent and treat viral hepatitis. In

hepatitis C, company researchers developed the first licensed

therapy for chronic HCV in 1991 and the first combination therapy in

1998. In addition to ongoing studies with boceprevir, extensive

research efforts are underway to develop additional innovative oral

therapies for viral hepatitis treatment.

References

1. Poordad, F. Boceprevir for Untreated Chronic HCV Genotype 1

Infection. N Engl J Med Vol. 364;13, 1195-1206.

2. Bacon, B. Boceprevir for Previously Treated Chronic HCV Genotype

1 Infection. N Engl J Med 2011. 364;13,1207-1217.

Source:

MSD

Article URL: http://www.medicalnewstoday.com/releases/231612.php

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Bill Eastman

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