Approval supported by TURQUOISE-III study showing 100 percent SVR12
(N=60/60) in chronic hepatitis C virus (HCV) infected genotype 1b
patients with compensated cirrhosis (Child-Pugh A)
Supplemental New Drug Application was previously granted priority
review designation by the FDA
WATERTOWN, Mass.--(BUSINESS WIRE)--Apr. 25, 2016--
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, announced today
that the U.S. Food and Drug Administration (FDA) has approved AbbVie’s
supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK®
(ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets)
without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic
hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh
A). The application was previously granted priority review by the FDA, a
designation given to investigational therapies that treat a serious
condition and provide a significant improvement in safety or
Paritaprevir is Enanta’s lead protease inhibitor identified within the
ongoing Enanta-AbbVie collaboration and is one of the direct-acting
antivirals in AbbVie’s VIEKIRA PAK®.
VIEKIRA PAK is a prescription medicine used with or without RBV
(depending on the sub-genotype of the patient’s HCV infection and other
factors) to treat adults with genotype 1 (GT1) chronic (lasting a long
time) HCV infection, including people who have a certain type of
cirrhosis (compensated). VIEKIRA PAK is not for people with more
advanced cirrhosis (decompensated). If people have cirrhosis, they
should talk to a doctor before taking VIEKIRA PAK.
The Centers for Disease Control and Prevention estimates that in the
United States, approximately 2.7 million people are chronically infected
with HCV.1 Genotype 1 is the most common HCV in the U.S.2
Of the total U.S. population with GT1 HCV infection, approximately 77
percent are genotype 1a (GT1a) and 23 percent are GT1b.2
“This new label supplement further validates the high SVR rates that
continue to evolve from the VIEKIRA PAK treatment regimen,” commented
Jay R. Luly, Ph.D., President and CEO. “Compensated cirrhotic HCV
patients are among the toughest to treat and the TURQUOISE-III study
demonstrated a cure rate of 100% with this regimen.”
The TURQUOISE-III study included in the sNDA evaluated the use of
VIEKIRA PAK without RBV for 12 weeks in GT1b patients with compensated
cirrhosis (Child-Pugh A). Results demonstrated 100 percent (N=60/60)
sustained virologic response at 12 weeks post-treatment (SVR12).
Patients who achieve SVR12 are considered cured of HCV, as
the virus is no longer detectable in the blood. No patients discontinued
treatment due to adverse events. The most commonly-reported adverse
events (≥10 percent) were fatigue (22 percent), diarrhea (20 percent),
headache (18 percent), arthralgia (10 percent), dizziness (10 percent),
insomnia (10 percent) and pruritus (10 percent).3
On February 26, AbbVie announced that the European Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMA) granted a positive opinion for VIEKIRAX®
(ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir
tablets) and this RBV-free option is now approved for use for the
treatment of chronic HCV infected GT1b patients with compensated
cirrhosis (Child-Pugh A) in Europe.
About the TURQUOISE-III Study
TURQUOISE-III is a multi-center, open-label, single arm Phase 3b study
to evaluate the safety and efficacy of 12 weeks of treatment with
VIEKIRA PAK without ribavirin (RBV) in adult patients (N=60) with
genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and
compensated liver cirrhosis (Child-Pugh A) who were treatment-naïve or
treatment-experienced (failed previous therapy with pegylated interferon
and RBV). The primary endpoint is the rate of sustained virologic
response 12 weeks after treatment (SVR12).1
IMPORTANT SAFETY INFORMATION FOR VIEKIRA PAK
When taking VIEKIRA PAK in combination with ribavirin, people should
read the Medication Guide that comes with ribavirin, especially the
important pregnancy information.
What is the most important information to know about VIEKIRA PAK?
VIEKIRA PAK may cause severe liver problems, especially in people with
certain types of cirrhosis. These severe liver problems can lead to
the need for a liver transplant, or can lead to death.
VIEKIRA PAK can cause increases in liver function blood test results,
especially if people use ethinyl estradiol-containing medicines (such
as some birth control products).
Ethinyl estradiol-containing medicines (combination birth control
pills or patches, such as Lo Loestrin® FE, Norinyl®, Ortho
Tri-Cyclen Lo®, Ortho Evra®; hormonal vaginal rings such as
NuvaRing®; and the hormone replacement therapy medicine, Fem HRT®)
must be stopped before starting treatment with VIEKIRA PAK. If
these medicines are used as a method of birth control, another
method must be used during treatment with VIEKIRA PAK, and for
about 2 weeks after treatment with VIEKIRA PAK ends. A
doctor can provide instruction on when to begin taking ethinyl
A doctor should do blood tests to check liver function during the
first 4 weeks of treatment and then as needed.
A doctor may tell people to stop taking VIEKIRA PAK if signs or
symptoms of liver problems develop. A doctor must be notified right
away if any of the following symptoms develop or if they worsen during
treatment with VIEKIRA PAK: tiredness, weakness, loss of appetite,
nausea, vomiting, yellowing of the skin or eyes, color changes in
stools, confusion, or swelling of the stomach area.
VIEKIRA PAK must not be taken if people:
have certain liver problems
take any of the following medicines: alfuzosin hydrochloride
(Uroxatral®) • carbamazepine (Carbatrol®, Epitol®, Equetro®,
Tegretol®, TEGRETOL-XR®) • cisapride (Propulisid®)• colchicine
(Colcrys®) • dronederone (Multag®)• efavirenz (Atripla®, Sustiva®) •
ergot containing medicines, including ergotamine tartrate (Cafergot®,
Ergomar®, Ergostat®, Medihaler®, Migergot®, Wigraine®, Wigrettes®),
dihydroergotamine mesylate (D.H.E. 45®, Migranal®), methylergonovine
(Ergotrate®, Methergine®) • ethinyl estradiol-containing medicines •
gemfibrozil (LOPID®) • lovastatin (Advicor®, Altoprev®, Mevacor®) •
lurasidone (Latuda®)• midazolam (when taken by mouth) • phenytoin
(Dilantin®, Phenytek®) • phenobarbital (Luminal®) • pimozide (Orap®) •
ranolazine (ranexa®) • rifampin (Rifadin®, Rifamate®, Rifater®,
Rimactane®) • sildenafil citrate (Revatio®), when taken for pulmonary
artery hypertension (PAH) • simvastatin (Simcor®, Vytorin®, Zocor®) •
St. John’s wort (Hypericum perforatum) or a product that contains St.
John’s wort • triazolam (Halcion®)
have had a severe skin rash after taking ritonavir (Norvir®)
What should people tell a doctor before taking VIEKIRA PAK?
If they have: liver problems other than hep C infection, HIV
infection, or any other medical conditions.
If they have had a liver transplant. If they take the medicines
tacrolimus (Prograf®) or cyclosporine (Gengraf®, Neoral®,
Sandimmune®), a doctor should check blood levels and, if needed, may
change the dose of these medicines or how often they are taken, both
during and after treatment with VIEKIRA PAK.
If they are pregnant or plan to become pregnant or if they are
breastfeeding or plan to breastfeed. It is not known if VIEKIRA PAK
will harm a person’s unborn baby or pass into breast milk. A doctor
should be consulted about the best way to feed a baby if taking
About all the medicines they take, including
prescription and over-the-counter medicines, vitamins, and herbal
supplements. Some medicines interact with VIEKIRA PAK.
A new medicine must not be started without telling a doctor.
A doctor will provide instruction on whether it is safe to take
VIEKIRA PAK with other medicines.
When VIEKIRA PAK is finished, a doctor should be consulted on what
to do if one of the usual medicines taken was stopped or if the
dose changed during VIEKIRA PAK treatment.
What are the common side effects of VIEKIRA PAK?
For VIEKIRA PAK used with ribavirin, side effects include
tiredness, nausea, itching, skin reactions such as redness or rash,
sleep problems, and feeling weak.
For VIEKIRA PAK used without ribavirin, side effects include
nausea, itching, and sleep problems.
These are not all of the possible side effects of VIEKIRA PAK. A doctor
should be notified if there is any side effect that is bothersome or
that does not go away.
This is the most important information to know about VIEKIRA PAK. For
more information, talk with a doctor.
People are encouraged to report negative side effects of prescription
drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
Please see full Prescribing Information including the Medication
If people cannot afford their medication, they should contact www.pparx.org
Additional Information about VIEKIRA PAK®
VIEKIRA PAK® has been studied in a broad range of genotype 1
(GT1) patients with chronic hepatitis C virus (HCV) infection, ranging
from treatment-naïve to difficult-to-treat patients, such as those with
compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1
co-infection, liver transplant recipients with normal hepatic function
and mild fibrosis, and those who have failed previous treatment with
pegylated interferon (pegIFN) and ribavirin (RBV). VIEKIRA PAK is
contraindicated in patients with moderate to severe hepatic impairment
(Child-Pugh B and C) due to risk of potential toxicity. VIEKIRA PAK
consists of the fixed-dose combination of ombitasvir 25mg (an NS5A
inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and
ritonavir 100mg (an HIV-1 protease inhibitor), dosed once daily with a
meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase
inhibitor), dosed twice daily with a meal. VIEKIRA PAK is taken for 12
weeks, except in GT1a patients with compensated cirrhosis, who should
take it for 24 weeks. Ribavirin should be co-administered in GT1a
patients, and in all patients who have received a liver transplant.
About VIEKIRAX® + EXVIERA®
VIEKIRAX + EXVIERA is approved in the European Union for the treatment
of genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including
patients with compensated cirrhosis. VIEKIRAX is approved in the
European Union for the treatment of genotype 4 (GT4) chronic HCV
VIEKIRAX tablets consist of the fixed-dose combination of paritaprevir
150mg (NS3/4A protease inhibitor) and ritonavir 100mg with ombitasvir
25mg (NS5A inhibitor), dosed once daily. EXVIERA tablets consist of
dasabuvir 250mg (non-nucleoside NS5B polymerase inhibitor) dosed twice
daily. VIEKIRAX + EXVIERA are taken with or without ribavirin (RBV),
dosed twice daily based on patient type. VIEKIRAX + EXVIERA is taken for
12 weeks with or without RBV, except in genotype 1a and GT4 patients
with compensated cirrhosis, who should take it for 24 weeks with RBV.
VIEKIRAX is indicated in combination with other medicinal products for
the treatment of chronic hepatitis C (CHC) in adults. EXVIERA is
indicated in combination with other medicinal products for the treatment
of CHC in adults.
Important EU Safety Information
VIEKIRAX + EXVIERA are contraindicated in patients with severe hepatic
impairment (Child-Pugh C). Patients taking ethinyl estradiol-containing
medicinal products must discontinue them and switch to an alternative
method of contraception prior to initiating VIEKIRAX + EXVIERA. Do not
give VIEKIRAX with certain drugs that are sensitive CYP3A substrates or
strong inhibitors of CYP3A. Do not give VIEKIRAX and EXVIERA with strong
or moderate enzyme inducers. Do not give EXVIERA with certain drugs that
are strong inhibitors of CYP2C8.
Special warnings and precautions for use:
VIEKIRAX and EXVIERA are not recommended as monotherapy and should be
used in combination with other medicinal products for the treatment of
hepatitis C infection.
Risk of Hepatic Decompensation and Hepatic Failure in Patients with
VIEKIRAX and EXVIERA are not recommended in patients
with moderate hepatic impairment (Child-Pugh B). Patients with cirrhosis
should be monitored for signs and symptoms of hepatic decompensation,
including hepatic laboratory testing at baseline and during treatment.
Transient elevations of ALT to >5x ULN
without concomitant elevations of bilirubin occurred in clinical trials
with VIEKIRAX + EXVIERA and were more frequent in a subgroup who were
using ethinyl estradiol-containing contraceptives.
Pregnancy and concomitant use with ribavirin
must be taken to avoid pregnancy in female patients and female partners
of male patients when VIEKIRAX with or without EXVIERA is taken in
combination with ribavirin, see section 4.6 and refer to the Summary of
Product Characteristics for ribavirin for additional information.
Use with concomitant medicinal products
Use caution when
administering VIEKIRAX with fluticasone or other glucocorticoids that
are metabolized by CYP3A4. A reduction in colchicine dosage or
interruption in colchicine is recommended in patients with normal renal
or hepatic function. VIEKIRAX with or without EXVIERA is expected to
increase exposure of statins so certain statins need to be discontinued
or dosages reduced. Low dose ritonavir, which is part of VIEKIRAX, may
select for PI resistance in HIV co-infected patients without ongoing
antiretroviral therapy. HIV co-infected patients without suppressive
antiretroviral therapy should not be treated with VIEKIRAX.
Most common (>20 percent) adverse reactions for VIEKIRAX + EXVIERA with
RBV were fatigue and nausea.
Full summary of product characteristics is available at www.ema.europa.eu
Globally, prescribing information varies; refer to the individual
country product label for complete information.
Enanta Pharmaceuticals is a research and development-focused
biotechnology company that uses its robust chemistry-driven approach and
drug discovery capabilities to create small molecule drugs for viral
infections and liver diseases. Enanta’s research and development is
currently focused on four disease targets: Hepatitis C Virus (HCV),
Hepatitis B Virus (HBV), Non-alcoholic Steatohepatitis (NASH) and
Respiratory Syncytial Virus (RSV).
Enanta has discovered novel protease inhibitors and NS5A inhibitors that
are members of the direct-acting-antiviral (DAA) inhibitor classes
designed for use against the hepatitis C virus (HCV). Enanta’s protease
inhibitors, developed through its collaboration with AbbVie, include
paritaprevir, which is contained in AbbVie’s marketed DAA regimens for
HCV, and ABT-493, Enanta’s protease inhibitor, which AbbVie is
developing in phase 3 studies in combination with ABT-530, AbbVie’s NS5A
inhibitor. Enanta has also discovered a cyclophilin inhibitor, EDP-494,
a novel host-targeting mechanism for HCV, which is now in phase 1
clinical development, and EDP-305, an FXR agonist, which Enanta plans to
advance into clinical development for NASH later in 2016. Please visit www.enanta.com
for more information on our programs and pipeline.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including
statements with respect to the prospects for AbbVie’s HCV treatment
regimens containing paritaprevir and Enanta’s other research and
development programs. Statements that are not historical facts are based
on management’s current expectations, estimates, forecasts and
projections about Enanta’s business and the industry in which it
operates and management’s beliefs and assumptions. The statements
contained in this release are not guarantees of future performance and
involve certain risks, uncertainties and assumptions, which are
difficult to predict. Therefore, actual outcomes and results may differ
materially from what is expressed in such forward-looking statements.
Important factors and risks that may affect actual results include: the
efforts of AbbVie (our collaborator marketing VIEKIRA PAK) to market and
sell VIEKIRA PAK; the development, regulatory and marketing efforts of
others with respect to competitive HCV treatment regimens; regulatory
and reimbursement actions affecting VIEKIRA PAK, any competitive
regimen, or both; and other risk factors described or referred to in
“Risk Factors” in Enanta’s most recent Form 10-K for the fiscal year
ended September 30, 2015 and any other periodic reports filed more
recently with the Securities and Exchange Commission. Enanta cautions
investors not to place undue reliance on the forward-looking statements
contained in this release. These statements speak only as of the date of
this release, and Enanta undertakes no obligation to update or revise
these statements, except as may be required by law.
1 Centers for Disease Control and Prevention (CDC). Hepatitis
C FAQs for health professionals. http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm.
Accessed February 4, 2016.
2 Wedemeyer H. Hepatitis C. Chapter 80: In: Feldman M,
Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal
and Liver Disease. Vol 2. 10th ed. Philadelphia, PA: Saunders Elsevier;
3 Feld JJ et al. Sustained virologic response of 100% in HCV
genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r
and dasabuvir for 12 weeks. J Hepatol (2015), http://dx.doi.org/10.1016/j.jhep.2015.10.005
View source version on businesswire.com: http://www.businesswire.com/news/home/20160425005823/en/
Source: Enanta Pharmaceuticals, Inc.
Enanta Pharmaceuticals, Inc.
Kari Watson, 781-235-3060