Boceprevir,
Merck's Investigational Oral Hepatitis C Protease Inhibitor,
Receives FDA Priority Review and EMA Accelerated Assessment
Whitehouse
Station, N.J., USA -- January 6, 2011 -- Merck, known as MSD
outside the United States and Canada, announced today that
regulatory applications for boceprevir, Merck's investigational
oral hepatitis C virus (HCV) protease inhibitor, were submitted
in 2010 and have been accepted for expedited review in both
the U.S. and the European Union.
The U.S. Food and Drug Administration (FDA) granted the New
Drug Application (NDA) for boceprevir Priority Review status,
a designation given to drugs that offer major advances in
treatment, or provide a treatment where no adequate therapy
exists. FDA's goal for completing a Priority Review is six
months.
Additionally, the European Medicines Agency (EMA) accepted
the Marketing Authorization Application (MAA) for boceprevir
for accelerated assessment. Accelerated assessment is available
for products that respond to unmet medical needs or represent
a significant improvement over current treatment options within
a major public health interest such as treatment of hepatitis
C virus infection.
Data in the NDA and MAA have been provided in support of the
proposed use of boceprevir for the treatment of chronic HCV
genotype 1 infection, in combination with standard therapy,
in adult patients with compensated liver disease who are previously
untreated or who have failed previous therapy.
"We are pleased that the FDA and EMA have accepted boceprevir
for expedited review. 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," said Dr. Peter
S. Kim, PhD, president, Merck Research Laboratories.
Merck's global commitment to advancing
hepatitis therapy
Merck 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. Extensive research efforts are underway to
develop differentiated oral therapies that bring innovation
to viral hepatitis care.
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.
