The First and Only All-Oral Interferon-Free
Treatment for Genotype 4 Chronic Hepatitis C in the U.S.
- Approval is supported by data from the
PEARL-I study, which demonstrated 100 percent sustained virologic
response rate at 12 weeks post-treatment (SVR12) in Genotype 4 HCV
patients who received TECHNIVIE and ribavirin for 12 weeks
- All-oral, two-direct-acting antiviral,
interferon-free treatment regimen contains paritaprevir, Enanta’s
lead protease inhibitor
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) approved
AbbVie’s TECHNIVIE™ (ombitasvir, paritaprevir and ritonavir)
tablets in combination with ribavirin (RBV) for the treatment of
non-cirrhotic adults with genotype 4 (GT4) chronic hepatitis C
virus (HCV) infection. TECHNIVIE is the first and only all-oral,
interferon-free, direct-acting antiviral treatment approved in the
U.S. for adult patients with GT4 chronic HCV infection.
“The approval of TECHNIVIE is an important advancement in the
care of patients with genotype 4 HCV,” commented Jay R. Luly,
President and CEO. “These difficult-to-treat patients now have a
treatment option with high cure rates available to them and we are
proud to have paritaprevir be part of this regimen.”
Paritaprevir is Enanta’s lead protease inhibitor identified
within the ongoing Enanta-AbbVie collaboration and is one of the
two direct-acting antivirals (2-DAA) in AbbVie’s TECHNIVIE. Forty
five percent of AbbVie’s worldwide net sales of the 2-DAA regimen
will be included in the paritaprevir net sales on which Enanta is
eligible to receive annually tiered royalties, ranging from the low
double digits up to twenty percent. AbbVie is responsible for all
worldwide development and commercialization of TECHNIVIE and other
HCV treatment regimens. Paritaprevir/ritonavir and ombitasvir,
AbbVie’s NS5A inhibitor, are also included in AbbVie’s VIEKIRA
PAK™, which was approved in the U.S. in late 2014 for patients with
GT1 HCV infection.
The Centers for Disease Control and Prevention (CDC) estimates
that 2.7 million people have chronic HCV infection in the U.S.1
There are six major HCV genotypes (GT1-6). While genotype 1 (GT1)
is the most prevalent form of HCV in the U.S., accounting for
approximately 74 percent of all cases2, GT4 infection is estimated
to account for approximately 1.1 percent of HCV infections in the
U.S.3
About the PEARL-I Study
This approval of TECHNIVIE is based on data from the PEARL-I
study, which demonstrated 100 percent sustained virologic response
rates at 12 weeks post-treatment (SVR12) in patients who received
TECHNIVIE and RBV for 12 weeks. PEARL-I is an open-label Phase 2b
study that evaluated the efficacy and safety of TECHNIVIE in GT4
chronic HCV patients without cirrhosis. The study included GT4
patients who were new to therapy (n=42/42) or who had failed
previous treatment with pegylated interferon (pegIFN) and RBV
(n=49/49). Additionally, 91 percent of patients who were new to
therapy achieved SVR12 (n=40/44) after taking TECHNIVIE without
RBV. In the treatment-naïve group without RBV, on-treatment
virologic breakthrough was reported in one patient (two percent),
and two patients (five percent) experienced post-treatment relapse.
There were no virologic failures in the other treatment arms.
There were no discontinuations due to adverse events in these
patients. The most commonly reported treatment-emergent adverse
events (greater than 10 percent in any group) observed in patients
receiving TECHNIVIE or TECHNIVIE with RBV, respectively, were
asthenia (weakness) (25-29 percent), fatigue (7-15 percent), nausea
(9-14 percent) and insomnia (5-13 percent). Four patients who
received TECHNIVIE with RBV experienced decreased hemoglobin
(anemia) which required RBV dose reductions; however, none of these
patients required blood transfusions or medication to boost their
red blood cell production. All patients treated with TECHNIVIE and
RBV achieved SVR12.
About TECHNIVIE
TECHNIVIE is an all-oral antiviral treatment consisting of the
fixed-dose combination of paritaprevir/ritonavir (150/100mg)
co-formulated with ombitasvir (25mg) dosed once daily and taken
with a meal, which is co-administered with weight-based RBV (1000mg
or 1200mg in divided doses, twice daily), taken with food. The
combination of two direct-acting antivirals, each with distinct
mechanisms of action, targets and inhibits specific HCV proteins in
the viral replication process.
Important Safety Information4
USE
TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir) tablets is
a prescription medicine used with ribavirin to treat adults with
genotype 4 chronic (lasting a long time) hepatitis C (hep C) virus
infection without cirrhosis.
TECHNIVIE is not for people with certain types of liver
problems.
IMPORTANT SAFETY INFORMATION
TECHNIVIE is taken 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
TECHNIVIE?
- TECHNIVIE 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
TECHNIVIE. If these medicines are used as a method of birth
control, another method must be used during treatment with
TECHNIVIE, and for about 2 weeks after treatment with
TECHNIVIE 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
TECHNIVIE 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 TECHNIVIE:
tiredness, weakness, loss of appetite, nausea, vomiting, yellowing
of the skin or eyes, or color changes in stools.
TECHNIVIE must not be taken if people:
- have severe liver problems
- take any of the following
medicines: alfuzosin hydrochloride (Uroxatral®) • carbamazepine
(Carbatrol®, Epitol®, Equetro®, Tegretol®) • 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 • 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®)
Before taking TECHNIVIE people should tell a doctor about all
their medical conditions, including:
- if they have liver problems other than
hep C infection or have HIV infection.
- 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
TECHNIVIE.
- if they are pregnant or plan to become
pregnant or if they are breastfeeding or plan to breastfeed. It is
not known if TECHNIVIE 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 TECHNIVIE.
- all the medicines they take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements. Some medicines interact with
TECHNIVIE.
- a new medicine must not be started
without telling a doctor. A doctor will provide instruction on
whether it is safe to take TECHNIVIE with other medicines.
- when TECHNIVIE 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 TECHNIVIE
treatment.
What are the common side effects of TECHNIVIE?
TECHNIVIE with ribavirin side effects include feeling
weak, tiredness, nausea, and sleep problems. These are not all of
the possible side effects of TECHNIVIE. 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
TECHNIVIE. 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.
For full Prescribing Information, click here or visit
rxabbvie.com/pdf/technivie_pi.pdf.
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 is
discovering, and in some cases developing, novel inhibitors
designed for use against the hepatitis C virus (HCV). These
inhibitors include members of the direct acting antiviral (DAA)
inhibitor classes – protease (partnered with AbbVie), NS5A, and
nucleotide polymerase – as well as a host-targeted antiviral (HTA)
inhibitor class targeted against cyclophilin. Enanta’s lead
protease inhibitor, paritaprevir, is part of AbbVie’s recently
approved HCV treatment regimens. In addition, Enanta has a
preclinical program in non-alcoholic steatohepatitis, or NASH,
which is a condition that results in liver inflammation and damage
caused by a buildup of fat in the liver.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including with respect to the prospects for AbbVie’s TECHNIVIE.
Statements that are not historical facts are based on our
management’s current expectations, estimates, forecasts and
projections about our business and the industry in which we operate
and our 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 that may affect actual results
include the efforts of AbbVie (our collaborator on paritaprevir)
regarding commercialization of TECHNIVIE; the level of market
acceptance and the pricing and rate of reimbursement for TECHNIVIE;
the impact of competitive products on the use and sales of
TECHNIVIE; 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.
2 O’Leary JG, Davis GL. Hepatitis C. In: Feldman M, Friedman LS,
Brandt LJ, eds. Sleisenger and Fordtran’s Gastrointestinal and
Liver Disease: Pathophysiology/Diagnosis/Management. 9th ed, Vol 1.
Philadelphia, PA: Saunders Elsevier.2010:1313-1335
3 Manos MM, Shvachko VA, Murphy RC, et al. Distribution of
hepatitis C virus genotypes in a diverse US integrated healthcare
population. J Med Virol. 2012 Nov; 84(11):1744-50.
4 TECHNIVIE [package insert]. North Chicago, IL: AbbVie Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20150724005749/en/
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMacDougall Biomedical
CommunicationsMedia ContactKari Watson,
781-235-3060kwatson@macbiocom.com
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