Enanta Announces U.S. FDA Approval of AbbVie’s MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) in as Little as 8 Weeks
- MAVYRET is a new, 8-week, pan-genotypic treatment for hepatitis C patients without cirrhosis and new to treatment
FDAapproval is supported by an overall 98 percent cure rate (rates ranged between 92-100 percent) in patients who received the recommended duration of treatment
- MAVYRET is approved for use across all stages of chronic kidney disease in patients with any of the major HCV genotypes
- MAVYRET may be used in up to 95 percent of HCV patients, depending on stage of liver disease and prior treatment history*
- Glecaprevir, one of the two new direct-acting antivirals (DAAs) in
MAVYRET, is Enanta’s second protease inhibitor being developed and
Following this approval of MAVYRET in the U.S., Enanta expects to
“A majority of the estimated 3.4 million Americans chronically infected
with HCV have not yet been treated for the disease and do not yet have
Approximately 3.4 million Americans are chronically infected with HCV.1 Additionally, HCV is common among people with severe CKD, with more than 500,000# people in the U.S. estimated to have both chronic HCV and CKD.2 MAVYRET was designed to deliver a cure** across all major genotypes and for specific treatment challenges, such as patients with severe CKD, and GT1 patients not cured by a NS5A inhibitor or a NS3/4A protease inhibitor (PI) in a direct-acting antiviral (DAA) treatment, but not both. MAVYRET combines two new DAAs that target and inhibit proteins essential for the replication of the hepatitis C virus.
The approval of MAVYRET is supported by data from nine registrational studies in AbbVie’s clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6) and special populations.
AbbVie’s pan-genotypic regimen also was recently granted marketing
authorization by the
*Ipsos Healthcare HCV Monitor, 2017.
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
#Based on IMS Dx (
About MAVYRET™ (glecaprevir/pibrentasvir)
MAVYRET® is approved by the
MAVYRET is an 8-week, pan-genotypic option for patients without cirrhosis and new to treatment, who comprise the majority of people living with HCV. MAVYRET is also approved as a treatment for patients with specific treatment challenges, including those (GT1) not cured by priortreatment experience with either a protease inhibitor or an NS5A inhibitor (but not both), and in patientswith limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is approved for use in patients across all stages of CKD with any of the major HCV genotypes (GT1-6).
Use and Important Safety Information
MAVYRET™ (glecaprevir and pibrentasvir) tablets are a prescription medicine used to treat adults with chronic (lasting a long time) hepatitis C virus (hep C) genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis.
IMPORTANT SAFETY INFORMATION
What is the most important information to know about MAVYRET?
Hepatitis B virus reactivation: Before starting treatment with MAVYRET, a doctor will do blood tests to check for hepatitis B virus infection. If people have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with MAVYRET. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. A doctor will monitor people if they are at risk for hepatitis B virus reactivation during treatment and after they stop taking MAVYRET.
MAVYRET must not be taken if people:
- Have certain liver problems
Are taking the medicines:
- atazanavir (Evotaz®, Reyataz®)
- rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®)
What should people tell a doctor before taking MAVYRET?
- If they have ever had hepatitis B virus infection, liver problems other than hep C infection, or any other medical conditions.
- If they are pregnant or plan to become pregnant, or if they are breastfeeding or plan to breastfeed. It is not known if MAVYRET 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 MAVYRET.
About all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. MAVYRET and other medicines may affect each other. This can cause people to have too much or not enough MAVYRET or other medicines in their body. This may affect the way MAVYRET or other medicines work, or may cause side effects.
- A new medicine must not be started without telling a doctor. A doctor will provide instruction on whether it is safe to take MAVYRET with other medicines.
What are the common side effects of MAVYRET?
- The most common side effects of MAVYRET are headache and tiredness.
These are not all of the possible side effects of MAVYRET. 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 MAVYRET. For more information, people should talk to a doctor or healthcare provider.
People are encouraged to report negative side effects of prescription
drugs to the
Please see full Prescribing Information, including the Patient Information.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including statements with respect to the prospects for commercialization of MAVYRET in
1 Messina JP, Humphreys I., Flaxman A., et.al. Global
distribution and prevalence of hepatitis C virus genotypes. Hepatology.
2015;61(1): 77-87 (and supplementary appendix).