- New once-daily, extended-release
co-formulation contains the three direct-acting antiviral
components of VIEKIRA PAK® for adult patients with genotype 1 (GT1)
chronic hepatitis C virus (HCV) infection
- Paritaprevir is Enanta’s lead protease
inhibitor and one of the three direct-acting antivirals in VIEKIRA
XR
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
approved AbbVie’s New Drug Application (NDA) for VIEKIRA XR™
(dasabuvir, ombitasvir, paritaprevir and ritonavir) extended
release tablets. VIEKIRA XR is a once-daily, extended-release
co-formulation of the active ingredients in VIEKIRA
PAK®(ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir
tablets) and is for the treatment of patients with chronic genotype
1 (GT1) hepatitis C virus (HCV) infection, including those with
compensated cirrhosis (Child-Pugh A). VIEKIRA XR is not for HCV
patients with decompensated cirrhosis.
Paritaprevir is Enanta’s lead protease inhibitor identified
within the ongoing Enanta-AbbVie collaboration and is one of the
three direct-acting antivirals in AbbVie’s VIEKIRA XR™.
VIEKIRA XR is the first co-formulated,
three-direct-acting-antiviral (DAA) treatment for adult patients
with GT1 HCV. VIEKIRA XR is given once-daily as three oral tablets
and must be taken with a meal. It is used without ribavirin (RBV)
in GT1b patients and in combination with twice daily RBV in GT1a
patients. The approval is supported by Phase 3 clinical trials for
VIEKIRA PAK which include data that demonstrated 100 percent
sustained virologic response 12 weeks following treatment (SVR12)
in GT1b patients with 12 weeks of therapy without ribavirin and 95
percent SVR12 in GT1a patients when used with ribavirin for 12 or
24 weeks of therapy.
“Our collaborative partner AbbVie has made great progress in
developing new treatments for patients living with HCV and we are
pleased to see FDA approval of this new, once-daily formulation of
the active ingredients in VIEKIRA PAK,” commented Jay R. Luly,
Ph.D., President and CEO.
There are six major HCV genotypes (GT1-6), with GT1 being the
most prevalent form of HCV in the U.S., accounting for
approximately 74 percent of all cases.1 Hepatitis C continues to be
an important public health issue, with The Centers for Disease
Control and Prevention (CDC) estimating that in the U.S.
approximately 2.7-3.9 million people are chronically infected with
HCV.2
The approval of VIEKIRA XR is supported by data from seven Phase
3 clinical trials in more than 2,300 patients who received VIEKIRA
PAK with or without RBV for 12 or 24 weeks and two bioavailability
studies comparing the two formulations.
About Clinical StudiesThe components of VIEKIRA XR
(administered twice daily with a meal) have been studied in seven
Phase 3 clinical trials where 1076 subjects (including 181 with
compensated cirrhosis) received the recommended regimen of VIEKIRA
+/− RBV for 12 weeks, or for 24 weeks in GT1a patients with
compensated cirrhosis. 95 to 100 percent achieved SVR12, which
means the hepatitis C virus is not detectable in the blood three
months after treatment ends. Cure rates varied by the subtype of
hepatitis C and whether or not the person had cirrhosis. Individual
results may vary.
About VIEKIRA XRThe components of VIEKIRA XR* have 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 or 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 XR, the extended-release co-formulation of the
components of VIEKIRA PAK, , consists of 200 mg of dasabuvir, 8.33
mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir
per tablet, and is dosed three tablets once daily. VIEKIRA XR must
be taken with a meal, and tablets should be swallowed whole. People
should not drink alcohol within four hours of taking VIEKIRA XR.
VIEKIRA XR is contraindicated in patients with moderate to severe
hepatic impairment (Child-Pugh B and C) due to risk of potential
toxicity. VIEKIRA XR is taken for 12 weeks, except in GT1a patients
with cirrhosis and all liver transplant recipients with normal
hepatic function and mild fibrosis, 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.
*Given as a 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.
USE
VIEKIRA XR™ (dasabuvir, ombitasvir, paritaprevir, and ritonavir)
extended-release tablets/VIEKIRA PAK® (ombitasvir, paritaprevir,
and ritonavir tablets; dasabuvir tablets) (VIEKIRA) are
prescription medicines used with or without ribavirin to treat
adults with genotype 1 chronic (lasting a long time) hepatitis C
(hep C) virus infection.
VIEKIRA can be used in people who have compensated
cirrhosis.
VIEKIRA is not for people with advanced cirrhosis
(decompensated). If people have cirrhosis, they should talk to a
doctor before taking VIEKIRA.
IMPORTANT SAFETY INFORMATION
When taking VIEKIRA 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?
• VIEKIRA 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 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. 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 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 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: 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 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, TERIL®) • cisapride (Propulsid®)
• colchicine (Colcrys®), in patients who have certain kidney or
liver problems • dronedarone (Multaq®) • 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?
• 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.
• If they are pregnant or plan to become pregnant or if they are
breastfeeding or plan to breastfeed. It is not known if VIEKIRA
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.
• About all the medicines they take, including prescription and
over-the-counter medicines, vitamins, and herbal supplements. Some
medicines interact with VIEKIRA.
• A new medicine must not be started without telling a doctor. A
doctor will provide instruction on whether it is safe to take
VIEKIRA with other medicines.
• When VIEKIRA 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 treatment.
What are the common side effects of VIEKIRA?
• For VIEKIRA used with ribavirin, side effects include
tiredness, nausea, itching, skin reactions such as redness or rash,
sleep problems, and feeling weak.
• For VIEKIRA used without ribavirin, side effects include
nausea, itching, and sleep problems.
These are not all of the possible side effects of VIEKIRA. 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.
For more information, talk to 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 VIEKIRA XR full Prescribing Information, including
the Medication Guide.
Please see VIEKIRA PAK full Prescribing Information, including
the Medication Guide.
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 second protease inhibitor. Enanta is eligible
to receive annually tiered, double-digit royalties on AbbVie’s
worldwide net sales allocable to each of the collaboration’s
protease inhibitor products and is eligible to receive up to $80
million in commercial regulatory approval milestones for
ABT-493.
About HCVHepatitis C is inflammation of the liver caused
by an infection with the hepatitis C virus. It is transmitted when
an infected person's blood enters the bloodstream of an uninfected
person. The Centers for Disease Control (CDC) estimates that
approximately 2.7-3.9 million people have chronic HCV infection in
the U.S. There are six major HCV genotypes (GT1-6), with genotype 1
(GT1) as the most prevalent form in the U.S. It is estimated that
of people infected with chronic HCV about 5 to 20 percent will go
on to develop cirrhosis over a period of 20–30 years, and with
HCV-related liver transplants on the rise, HCV is a critical public
health issue. Presently, there is no vaccine to protect against HCV
infection.
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’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 developed direct-acting-antiviral (DAA) inhibitors
designed for use against 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 second 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. In addition, Enanta has early
lead candidates for HBV and RSV in preclinical testing. Please
visit www.enanta.com for more information on Enanta’s programs and
pipeline.
Forward-Looking StatementsThis press release contains
forward-looking statements, including statements with respect to
the prospects for VIEKIRA XR. 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 XR) to
commercialize VIEKIRA XR; the development, regulatory and marketing
efforts of others with respect to competitive HCV treatment
regimens; regulatory and reimbursement actions affecting VIEKIRA
XR, 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 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.
2 Centers for Disease Control and Prevention (CDC). Hepatitis C
FAQs for health professionals.
http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm. Accessed July 11,
2016.
3 AbbVie 2016 Impact by the Numbers.
http://www.abbvie.com/responsibility/home.html
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160725006337/en/
Investor Contact:Enanta Pharmaceuticals, Inc.Carol
Miceli, 617-607-0710cmiceli@enanta.comorMedia
Contact:MacDougall Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Enanta Pharmaceuticals (NASDAQ:ENTA)
Historical Stock Chart
From Sep 2023 to Sep 2024