- Decision from FDA on New Drug
Application anticipated in second half of 2016
- Regimen 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 AbbVie’s New Drug Application (NDA) has been accepted by
the U.S. Food and Drug Administration (FDA) for a once-daily,
fixed-dose formulation of the components of VIEKIRA PAK®
(ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir
tablets). VIEKIRA PAK is an all-oral, interferon-free treatment
approved with or without ribavirin (RBV) in the United States for
patients with genotype 1 (GT1) chronic hepatitis C virus (HCV)
infection, including those with compensated cirrhosis. VIEKIRA PAK
is not for people with advanced decompensated cirrhosis.
The proposed dosing for the fixed-dose formulation (dasabuvir,
ombitasvir, paritaprevir, ritonavir tablets) is three oral tablets
once daily with a meal, with or without twice-daily RBV, which may
offer another important treatment option for people living with GT1
HCV. The NDA filing is supported by data from two bioavailability
studies. Currently, VIEKIRA PAK is given twice daily as three
tablets in the morning and one tablet in the evening, taken with a
meal.
The Centers for Disease Control and Prevention (CDC) estimates
that in the United States, approximately 2.7 million people are
chronically infected with HCV.1 Genotype 1 is the most prevalent
form of HCV in the U.S., accounting for approximately 74 percent of
all cases.2 Hepatitis C is inflammation of the liver caused by an
infection with HCV. It is transmitted when an infected person's
blood enters the bloodstream of an uninfected person. There are six
major HCV genotypes (GT1-6). Presently, there is no vaccine for HCV
infection.
About VIEKIRA PAK
USE
VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets;
dasabuvir tablets) is a prescription medicine used with or without
ribavirin to treat adults with genotype 1 chronic (lasting a long
time) hepatitis C (hep C) virus 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.
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,
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-naive 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.
Protease Inhibitor Collaboration with AbbVie (formerly the
research-based pharmaceutical business of Abbott
Laboratories)In December 2006, Enanta and Abbott announced a
worldwide agreement to collaborate on the discovery, development
and commercialization of HCV NS3 and NS3/4A protease inhibitors and
HCV- protease-inhibitor-containing drug combinations. Paritaprevir
and ABT-493 are protease inhibitors identified through the
collaboration. Under the agreement, AbbVie is responsible for all
development and commercialization activities for the
collaboration’s lead compound, paritaprevir, as well as ABT-493,
the collaboration’s next-generation protease inhibitor. Enanta is
eligible to receive annually tiered, double-digit royalties per
product on AbbVie’s worldwide net sales allocable to any of the
collaboration’s protease inhibitor products.
About EnantaEnanta 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 discovered novel protease and NS5A inhibitors that are
direct-acting-antivirals (DAAs) 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 next-generation protease inhibitor which recently
entered phase 3 development in combination with ABT-530, AbbVie’s
next-generation NS5A inhibitor. Enanta has also 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 quarter ending March 31, 2016. In addition,
Enanta has a preclinical program in non-alcoholic steatohepatitis,
or NASH, which is a condition that results in liver inflammation
and liver damage caused by a buildup of fat in the liver.
Forward Looking Statements DisclaimerThis press release
contains forward-looking statements, including statements with
respect to the prospects for FDA approval of a once daily
formulation of AbbVie’s 3-DAA HCV treatment regimen containing
paritaprevir. 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: Enanta’s revenues are dependent upon the success
of AbbVie’s planned regulatory approval and commercialization
efforts for its treatment regimens containing paritaprevir; the
pricing, market acceptance and reimbursement rates of treatment
regimens containing paritaprevir or ABT-493 compared to competitive
HCV products on the market and product candidates of other
companies under development; 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, 2014 and 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. Hepatitis C FAQs
for Health Professionals. Centers for Disease Control and
Prevention website. http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm.
Accessed November 30, 2015
2 Wedemeyer H. Hepatitis C. In: Feldman M, Friedman LS, Brandt
LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and Liver
Disease: Pathophysiology/Diagnosis/Management. 10th ed, Vol 2.
Philadelphia, PA: Saunders Elsevier. 2016:1332-1351
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version on businesswire.com: http://www.businesswire.com/news/home/20151202005726/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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