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|Enanta Announces U.S. Food and Drug Administration Approves AbbVie’s VIEKIRA PAK™ (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C Virus|
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
“Enanta is proud to have paritaprevir be part of such an important
medicine for the treatment of HCV,” stated
The approval of VIEKIRA PAK is supported by a robust clinical
development program conducted by
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.
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
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).
VIEKIRA PAK must not be taken if people:
What should people tell a healthcare provider before taking VIEKIRA PAK?
What are the common side effects of VIEKIRA PAK?
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
Protease Inhibitor Collaboration with
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