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European Committee Recommends Boceprevir (Victrelis)

SUMMARY
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of the HCV protease inhibitor boceprevir (brand name Victrelis) for treatment of chronic hepatitis C.

As previously reported, the U.S. Food and Drug Administration last week approved boceprevir for treatment of treatment-naive or prior non-responder patients with genotype 1 hepatitis C virus (HCV) infection, in combination with pegylated interferon plus ribavirin.

Below is an edited excerpt from a press release issued by boceprevir developer Merck announcing the European recommendation.


CHMP Issues Positive Opinion for Merck's Victrelis (Boceprevir), Oral Hepatitis C Virus (HCV) Protease Inhibitor

Whitehouse Station, NJ -- May 20, 2011 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine Victrelis (boceprevir) for the treatment of chronic hepatitis C virus (HCV) 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.

The positive opinion will be reviewed by the European Commission, which grants marketing authorization with unified labeling that is valid in the 27 countries that are members of the European Union (EU), as well as European Economic Area members, Iceland, Liechtenstein and Norway.

"We are pleased with CHMP's recommendation to approve Victrelis in combination with current standard therapy," said Peter S. Kim, PhD, president, Merck Research Laboratories. "If approved, Victrelis would represent the first in a new class of medicines known as HCV protease inhibitors granted marketing authorization in the European Union, and would offer an important new treatment option for patients with chronic hepatitis C genotype 1."

The CHMP positive opinion for Victrelis in combination with current standard therapy 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. The HCV SPRINT-2 study involved 1,097 patients who were new to treatment (treatment naïve) and the HCV RESPOND-2 study involved 403 patients who had failed previous therapy. Final results of the studies were published in the New England Journal of Medicine on March 31, 2011.

Victrelis is a Direct Acting Antiviral (DAA) agent designed to interfere with the ability of the hepatitis C virus to replicate by inhibiting a key viral enzyme (NS3/4A serine protease).

Victrelis in the U.S.: First-in-class oral HCV protease inhibitor now available nationwide Victrelis was approved by the U.S. Food and Drug Administration on May 13 and is now available to all U.S. pharmacies nationwide, including specialty pharmacies. Any U.S. pharmacy can order VICTRELIS through its wholesaler and have it delivered within 24 hours.

To support the availability of Victrelis in the U.S., the company has launched the Merck CARES (Commitment to Access, Resources, Education & Support) program, which offers U.S. patients and providers a single point of access for resources and support needed to help patients as they initiate HCV treatment. Resources include reimbursement support to help patients understand their insurance coverage for Victrelis and 24/7 nurse phone support. Eligible patients can also be referred to Merck's patient assistance program, which can determine if the patient qualifies for free product. Patients and providers can access the Merck CARES resources at 1-866-939-HEPC (4372).

Victrelis is indicated in the U.S. for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.

The following points should be considered when initiating Victrelis for treatment of chronic hepatitis C infection:


Victrelis must not be used as monotherapy and should only be used in combination with peginterferon alfa and ribavirin.
Victrelis efficacy has not been studied in patients who have previously failed therapy with a treatment regimen that includes Victrelis or other HCV NS3/4A protease inhibitors.
Victrelis in combination with peginterferon alfa and ribavirin has not been studied in patients documented to be historical null responders (less than a 2 log HCV-RNA decline by treatment week 12) during prior therapy with peginterferon alfa and ribavirin. The clinical studies included patients who were poorly interferon responsive. Patients with less than 0.5 log HCV-RNA decline in viral load at treatment week 4 with peginterferon alfa plus ribavirin alone are predicted to have a null response (less than a 2 log HCV-RNA decline by treatment week 12) to peginterferon alfa and ribavirin therapy.
Poorly interferon responsive patients who were treated with Victrelis in combination with peginterferon alfa and ribavirin have a lower likelihood of achieving a sustained virologic response (SVR), and a higher rate of detection of resistance-associated substitutions upon treatment failure, compared to patients with a greater response to peginterferon alfa and ribavirin.

The complete press release, including important safety information about Victrelis, is available at http://www.merck.com/newsroom/news-release-archive/prescription-medicine-news/2011_0520.html.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.

5/20/11

Source
Merck. CHMP Issues Positive Opinion for Merck's Victrelis (Boceprevir), Oral Hepatitis C Virus (HCV) Protease Inhibitor. May 20, 2011.



 



 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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