- VIEKIRA PAK regimen contains Enanta’s
lead protease inhibitor, paritaprevir (formerly ABT-450)
- In Phase 3 clinical trials, VIEKIRA PAK
cured 95-100 percent of hepatitis C patients, with less than two
percent of patients experiencing virological failure
- Tolerability profile shows more than 98
percent of patients completed a full course of therapy
- All oral interferon-free regimen
approved for HCV/HIV-1 co-infection and patients who have undergone
a liver transplant
Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA) a research and
development-focused biotechnology company dedicated to creating
small molecule drugs primarily in the infectious disease field,
today announced the U.S. Food and Drug Administration (FDA) has
approved AbbVie’s VIEKIRA PAK™ (ombitasvir/paritaprevir/ritonavir
tablets; dasabuvir tablets) with or without ribavirin for the
treatment of genotype 1 (GT1) patients with chronic hepatitis C
virus (HCV) infection, including those with compensated
cirrhosis.
Paritaprevir (formerly known as ABT-450) is Enanta’s lead
protease inhibitor identified within the ongoing Enanta-AbbVie
collaboration and is one of three direct-acting antivirals (DAAs)
in the VIEKIRA PAK regimen. AbbVie is responsible for all worldwide
development and commercialization of VIEKIRA PAK and other regimens
containing paritaprevir. The U.S. approval of VIEKIRA PAK triggers
a $75 million regulatory approval milestone payment to Enanta from
AbbVie.
“Enanta is proud to have paritaprevir be part of such an
important medicine for the treatment of HCV,” stated Jay R. Luly,
Ph.D., President and CEO. “This important achievement will fuel and
energize Enanta’s continued pursuit of drugs to treat infectious
diseases where there is significant medical need.”
The approval of VIEKIRA PAK is supported by a robust clinical
development program conducted by AbbVie and designed to study the
safety and efficacy of the regimen in more than 2,300 enrolled
patients across 25 countries. The program consisted of six pivotal
Phase 3 studies, which demonstrated that VIEKIRA PAK cured 95-100
percent of GT1a and GT1b hepatitis C patients, including patients
new and experienced to treatment, and patients with compensated
cirrhosis, with less than two percent of patients experiencing
virological failure. Additionally, more than 98 percent of patients
in clinical trials completed a full course of therapy.
VIEKIRA PAK’s approval is also based on the results from Phase 2
clinical trials evaluating tougher-to-cure patient populations,
which showed that VIEKIRA PAK cured 97 percent of liver transplant
recipients with HCV and 92 percent of patients co-infected with
HCV/HIV-1. Patients who achieve a sustained virologic response
(SVR12) are considered cured of HCV.
VIEKIRA PAK was granted priority review and designated as a
Breakthrough Therapy by the U.S. FDA, a status given to medicines
or regimens that may offer substantial improvement over available
therapies.
About VIEKIRA PAK™
VIEKIRA PAK™ (ombitasvir/paritaprevir/ritonavir tablets;
dasabuvir tablets) has been studied in a broad range of genotype 1
(GT1) patients with chronic hepatitis C virus (HCV) infection,
ranging from treatment-naïve to some of the most difficult to
treat, such as patients 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 not recommended in
patients with moderate hepatic impairment (Child-Pugh B), and is
contraindicated in patients with severe hepatic impairment
(Child-Pugh C). 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 approved 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 patients with genotype 1a and 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.
Full Prescribing Information, including the Medication Guide,
can be found here.
Use and Important Safety Information from AbbVie
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 virus (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
healthcare provider before taking VIEKIRA PAK.
IMPORTANT SAFETY
INFORMATION
When taking VIEKIRA PAK in combination with ribavirin, people
should also 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 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
healthcare provider can provide instruction on when to begin taking
ethinyl estradiol-containing medicines.
- A healthcare provider should do blood
tests to check liver function during the first 4 weeks of treatment
and then as needed.
- A healthcare provider may tell people
to stop taking VIEKIRA PAK if signs or symptoms of liver problems
develop. A healthcare provider 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, or color changes
in stools.
VIEKIRA PAK 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 • 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 healthcare provider before taking
VIEKIRA PAK?
- If they have: liver problems other than
HCV 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 healthcare provider 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 healthcare provider should be consulted about
the best way to feed a baby if taking VIEKIRA PAK. For pregnant
females that have both HCV and HIV infection, they should talk with
a healthcare provider 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 healthcare provider. A healthcare provider will
provide instruction on whether it is safe to take VIEKIRA PAK with
other medicines.
- When VIEKIRA PAK is finished, a
healthcare provider 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
healthcare provider 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 with a healthcare provider.
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.
Protease Inhibitor Collaboration with AbbVie
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
(ABT-450) 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.
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 primarily in the infectious disease field. 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.
Forward Looking Statements Disclaimer
This press release contains forward-looking statements,
including with respect to the prospects for milestone and royalty
payments to Enanta related to AbbVie’s paritaprevir-containing
VIEKIRA PAK and Enanta’s prospects for its continued pursuit of
other potential drugs. 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 commercialization efforts of
AbbVie (our collaborator on paritaprevir) regarding VIEKIRA PAK and
other treatment regimens containing paritaprevir, market acceptance
of those regimens, the impact of competitive products on the use
and sales of those regimens, and regulatory actions affecting
clinical development of paritaprevir and clinical development of
competitive product candidates outside of the United States. 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.
Investor ContactEnanta Pharmaceuticals, Inc.Carol Miceli,
617-607-0710cmiceli@enanta.comorMedia ContactMacDougall
Biomedical CommunicationsKari Watson,
781-235-3060kwatson@macbiocom.com
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