- 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
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 effectiveness.
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 estradiol-containing medicines.
- 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 VIEKIRA PAK.
- 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 Guide.
If people cannot afford their medication, they should
contact www.pparx.org for assistance.
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 infection.
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.
EU Indication
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
Contraindications:
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 CirrhosisVIEKIRAX 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.
ALT elevationsTransient 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 ribavirinExtreme caution 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 productsUse 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.
Adverse Reactions
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.
About Enanta
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;
2016.
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
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version on businesswire.com: http://www.businesswire.com/news/home/20160425005823/en/
InvestorsEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMediaMacDougall Biomedical
CommunicationsKari Watson, 781-235-3060kwatson@macbiocom.com
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