Merck Receives Positive CHMP Opinion for ZEPATIER™ (elbasvir and grazoprevir) in the European Union
May 27, 2016 6:46 am ET
KENILWORTH, N.J.–(BUSINESS WIRE)–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 recommending approval of ZEPATIER™ (elbasvir and
grazoprevir), an investigational, once-daily, fixed-dose combination
tablet for the treatment of chronic hepatitis C virus (HCV) in adult
patients. The CHMP positive opinion will be reviewed by the European
Commission. If the European Commission affirms the CHMP opinion, it will
grant a centralized marketing authorization with unified labeling that
is valid in the 28 countries that are members of the European Union, as
well as European Economic Area members, Iceland, Liechtenstein and
Norway. Merck anticipates that the European Commission decision will be
made in mid-2016. The company continues to work to achieve manufacturing
readiness to supply the EU market, with product launches estimated to
begin in the fourth quarter of 2016 or the first quarter of 2017.
The U.S. Food and Drug Administration and Health Canada approved
ZEPATIER 50mg/100mg tablets in January 2016. In the United States,
ZEPATIER is indicated for the treatment of adult patients with chronic
HCV genotype 1 or 4 infection, with or without ribavirin (RBV).
“We are pleased with the CHMP’s positive opinion recommending the
marketing authorization of ZEPATIER in the European Union, which marks
an important step forward in the European regulatory process,” said Dr.
Roy Baynes, senior vice president and head of clinical development,
Merck Research Laboratories. “Our application was based on the findings
from a broad clinical development program evaluating the efficacy and
safety of ZEPATIER across diverse populations of patients with chronic
hepatitis C, including patients with compensated cirrhosis and those
with stage 4 or 5 chronic kidney disease.”
Selected Safety Information about ZEPATIER (elbasvir and grazoprevir)
ZEPATIER is not for use in patients with moderate or severe hepatic
impairment (Child Pugh B or C). ZEPATIER is also not for use with
organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors
(e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir,
cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g.,
carbamazepine, phenytoin, rifampin, St. John’s Wort), and efavirenz. If
ZEPATIER is administered with RBV, healthcare professionals should refer
to the prescribing information for RBV as the contraindications,
warnings and precautions, adverse reactions and dosing for RBV also
apply to this combination regimen.
Elevations of alanine transaminase (ALT) to greater than 5 times the
upper limit of normal (ULN) occurred in 1% of subjects, generally at or
after treatment week 8. These late ALT elevations were typically
asymptomatic and most resolved with ongoing or completion of therapy.
Healthcare professionals should perform hepatic lab testing on patients
prior to therapy, at treatment week 8, and as clinically indicated. For
patients receiving 16 weeks of therapy, additional hepatic lab testing
should be performed at treatment week 12.
Patients should be instructed to consult their healthcare professional
without delay if they have onset of fatigue, weakness, lack of appetite,
nausea and vomiting, jaundice or discolored feces. Healthcare providers
should consider discontinuing ZEPATIER if ALT levels remain persistently
greater than 10 times ULN. ZEPATIER should be discontinued if ALT
elevation is accompanied by signs or symptoms of liver inflammation or
increasing conjugated bilirubin, alkaline phosphatase, or international
normalized ratio.
The concomitant use of ZEPATIER with certain drugs may lead to adverse
reactions or reduced therapeutic effect due to drug interactions.
Certain strong CYP3A inhibitors may increase the plasma concentration of
ZEPATIER, leading to possibly clinically significant adverse reactions.
Moderate CYP3A inducers may decrease the plasma concentration of
ZEPATIER, leading to reduced therapeutic effect and possible development
of resistance. Coadministration of ZEPATIER with these drugs is not
recommended. Physicians should consult the Prescribing Information for
potential drug interactions.
In subjects receiving ZEPATIER for 12 weeks, the most commonly reported
adverse reactions of all intensity (greater than or equal to 5% in
placebo-controlled trials) were fatigue, headache and nausea. In
subjects receiving ZEPATIER with RBV for 16 weeks, the most commonly
reported adverse reactions of moderate or severe intensity (greater than
or equal to 5%) were anemia and headache.
About ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg Tablets
ZEPATIER is a fixed-dose combination product containing elbasvir, a
hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A
protease inhibitor, and is indicated with or without ribavirin for
treatment of chronic HCV genotype 1 or 4 infection in adults. ZEPATIER
is a single tablet taken once daily. The recommended dosing is 12 or 16
weeks with or without RBV, depending on HCV genotype, prior treatment
history and, for patients with genotype 1a infection, presence of
certain baseline NS5A resistance-associated polymorphisms. See
Prescribing Information for ZEPATIER for specific dosage regimens and
durations. Refer to RBV prescribing information for RBV dosing and
dosage modifications when ZEPATIER is given with RBV. To determine
dosage regimen and duration of ZEPATIER for genotype 1a patients,
testing for the presence of virus with one or more baseline NS5A
resistance-associated polymorphisms at positions 28, 30, 31, or 93 is
recommended prior to initiating treatment.
Merck’s Commitment to HCV
For more than 30 years, Merck has been at the forefront of the response
to the HCV epidemic. Merck employees are dedicated to applying their
scientific expertise, resources and global reach to develop and deliver
innovative healthcare solutions to support people living with chronic
HCV worldwide.
About Merck
For 125 years, Merck has been a global health care 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 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
health care through far-reaching policies, programs and partnerships.
For more information, visit www.merck.com
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This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
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significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
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Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
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United States and internationally; global trends toward health care cost
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The company undertakes no obligation to publicly update any
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future events or otherwise. Additional factors that could cause results
to differ materially from those described in the forward-looking
statements can be found in the company’s 2015 Annual Report on Form 10-K
and the company’s other filings with the Securities and Exchange
Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for ZEPATIER (elbasvir and
grazoprevir) at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_pi.pdf
and the Patient Information for ZEPATIER at http://www.merck.com/product/usa/pi_circulars/z/zepatier/zepatier_ppi.pdf
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