- Priority review designation shortens
the regulatory review period from the standard 10 months to six
months
- TURQUOISE-III study showed 100 percent
sustained virologic response at 12 weeks post-treatment (SVR12) in
patients with genotype 1b (GT1b) chronic hepatitis C virus and
compensated cirrhosis (Child-Pugh A)
- VIEKIRA PAK contains Enanta’s lead
protease inhibitor, paritaprevir
Enanta Pharmaceuticals, Inc., (NASDAQ:ENTA) a research and
development-focused biotechnology company dedicated to creating
small molecule drugs for viral infections and liver diseases, today
announced that the U.S. Food and Drug Administration (FDA) has
accepted AbbVie’s supplemental New Drug Application (sNDA) and
granted priority review for VIEKIRA PAK® (ombitasvir, paritaprevir,
and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV)
in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV)
and compensated cirrhosis (Child-Pugh A). The current dosing
recommendation for patients with GT1b and compensated cirrhosis is
to administer RBV with VIEKIRA PAK for 12 weeks.
The FDA grants priority review designation to investigational
therapies that treat a serious condition and, if approved, would
provide a significant improvement in safety or effectiveness. The
priority designation shortens the regulatory review period from the
standard 10 months to 6 months.
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 treatment regimens
for chronic hepatitis C virus (HCV).
VIEKIRA PAK is a prescription medicine used with or without
ribavirin to treat adults with genotype 1 (GT1) chronic HCV
infection, including people who have a certain type of cirrhosis
(compensated). VIEKIRA PAK is not for people with advanced
cirrhosis (decompensated). If people have cirrhosis, they should
talk to a doctor before taking VIEKIRA PAK.
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). 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).1
The Centers for Disease Control and Prevention (CDC) estimates
that in the United States, 2.7 million people are chronically
infected with HCV.2 Genotype 1 is the most common HCV in the U.S.3
Of the total U.S. population with GT1 HCV infection, approximately
77 percent have GT1a HCV infection and 23 percent have GT1b.3
About the TURQUOISE-III Study
TURQUOISE-III is a multi-center, open-label 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
About VIEKIRA PAK
IMPORTANT SAFETY INFORMATION
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®) • colchicine (Colcrys®)
• efavirenz (Sustiva®, Atripla®) • ergot containing medicines,
including ergotamine tartrate (Cafergot®, Migergot®, Ergomar®,
Ergostat®, Medihaler®, Wigraine®, Wigrettes®), dihydroergotamine
mesylate (D.H.E. 45®, Migranal®), methylergonovine (Ergotrate®,
Methergine®) • ethinyl estradiol-containing medicines • gemfibrozil
(Lopid®) • lovastatin (Advicor®, Altoprev®, Mevacor®) • midazolam
(when taken by mouth) • phenytoin (Dilantin®, Phenytek®) •
phenobarbital (Luminal®) • pimozide (Orap®) • rifampin (Rifadin®,
Rifamate®, Rifater®, Rimactane®) • sildenafil citrate (Revatio®),
when taken for pulmonary artery hypertension (PAH) • simvastatin
(Zocor®, Vytorin®, Simcor®) • 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. Pregnant females who have
both hep C and HIV infection should talk with a doctor about
enrolling in the antiretroviral pregnancy registry.
- 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.
Click here for 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 cirrhosis, who should take
it for 24 weeks. Ribavirin should be co-administered in GT1a
patients, and in all patients who have cirrhosis or who have
received a liver transplant.
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 has developed
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 partnered with AbbVie include paritaprevir, which is
contained in AbbVie’s marketed DAA regimens for HCV, and ABT-493,
Enanta’s next-generation protease inhibitor which AbbVie is
developing in phase 3 studies in combination with ABT-530, AbbVie’s
next-generation NS5A inhibitor. Enanta also has discovered EDP-494,
a host-targeted antiviral (HTA) inhibitor for HCV targeted against
cyclophilin, which Enanta plans to study in a phase 1 clinical
trial beginning in the first quarter of calendar 2016. In addition,
Enanta plans to advance into clinical development later in 2016 its
program in non-alcoholic steatohepatitis, or NASH, a condition that
results in liver inflammation and liver damage caused by a buildup
of fat in the liver.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including statements with respect to the prospects for FDA approval
under priority review of the sNDA for VIEKIRA PAK. 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 on paritaprevir that is
marketing VIEKIRA PAK) to obtain regulatory approval of the sNDA
for 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 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
2 Centers for Disease Control and Prevention (CDC). Hepatitis C
FAQs for health professionals.
http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Accessed December 17,
2015.
3 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160107005707/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Jul 2023 to Jul 2024