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FDA Press Release
FDA approves Mavyret for Hepatitis C
The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.
Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more.
“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the Centers for Disease Control and Prevention, an estimated 2.7 to 3.9 million people in the United States have chronic HCV. Some patients who suffer from chronic HCV infection over many years may have jaundice (yellowish eyes or skin) and complications, such as bleeding, fluid accumulation in the abdomen, infections, liver cancer and death.
There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. Knowing the strain of the virus can help inform treatment recommendations. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small number of patients are infected with genotypes 4, 5 or 6.
The safety and efficacy of Mavyret were evaluated during clinical trials enrolling approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that 92-100 percent of patients who received Mavyret for eight, 12 or 16 weeks duration had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured.
Treatment duration with Mavyret differs depending on treatment history, viral genotype, and cirrhosis status.
The most common adverse reactions in patients taking Mavyret were headache, fatigue and nausea.
Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.
Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Mavyret.
The FDA granted this application Priority Review and Breakthrough Therapy designations.
The FDA granted approval of Mavyret to AbbVie Inc.
Research & Media Articles
Download
HIGHLIGHTS OF PRESCRIBING INFORMATION
FDA Press Release
FDA approves Mavyret for Hepatitis C
The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.
Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more.
“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. According to the Centers for Disease Control and Prevention, an estimated 2.7 to 3.9 million people in the United States have chronic HCV. Some patients who suffer from chronic HCV infection over many years may have jaundice (yellowish eyes or skin) and complications, such as bleeding, fluid accumulation in the abdomen, infections, liver cancer and death.
There are at least six distinct HCV genotypes, or strains, which are genetically distinct groups of the virus. Knowing the strain of the virus can help inform treatment recommendations. Approximately 75 percent of Americans with HCV have genotype 1; 20-25 percent have genotypes 2 or 3; and a small number of patients are infected with genotypes 4, 5 or 6.
The safety and efficacy of Mavyret were evaluated during clinical trials enrolling approximately 2,300 adults with genotype 1, 2, 3, 4, 5 or 6 HCV infection without cirrhosis or with mild cirrhosis. Results of the trials demonstrated that 92-100 percent of patients who received Mavyret for eight, 12 or 16 weeks duration had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured.
Treatment duration with Mavyret differs depending on treatment history, viral genotype, and cirrhosis status.
The most common adverse reactions in patients taking Mavyret were headache, fatigue and nausea.
Mavyret is not recommended in patients with moderate cirrhosis and contraindicated in patients with severe cirrhosis. It is also contraindicated in patients taking the drugs atazanavir and rifampin.
Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected adult patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy. HBV reactivation in patients treated with direct-acting antiviral medicines can result in serious liver problems or death in some patients. Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with Mavyret.
The FDA granted this application Priority Review and Breakthrough Therapy designations.
The FDA granted approval of Mavyret to AbbVie Inc.
MAVYRET is a new 8-week, pan-genotypic treatment for hepatitis C patients without cirrhosis and who are new to treatment
- FDA approval 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 a pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease
- MAVYRET may be used in up to 95 percent of HCV patients, depending on stage of liver disease and prior treatment history*
NORTH CHICAGO, Ill., Aug. 3, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved MAVYRET™ (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). MAVYRET is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment. Up to 95 percent of HCV patients in the U.S. may be eligible for treatment with MAVYRET, including patients with compensated cirrhosis or without cirrhosis and those with limited treatment options, such as patients with chronic kidney disease (CKD).*
"With MAVYRET, physicians and patients now have a treatment option that is highly effective and has the potential to cure the majority of HCV patients in as short as 8 weeks, regardless of genotype," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "The approval of MAVYRET demonstrates AbbVie's commitment to advancing science to help address unmet needs by delivering a new cure for patients who historically had limited treatment options, including those with genotype 3 HCV, individuals with CKD and certain DAA failure patients."
Approximately 3.4 million Americans are chronically infected with HCV.1 Additionally, HCV is common among people with severe CKD, with an estimated more than 500,000ⱡ people having both chronic HCV and CKD.2 MAVYRET was designed to deliver a cure** across all major genotypes and 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) 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 clinical trial program for MAVYRET resulted in high cure rates across a range of patient populations, from those who have never been treated and who do not have cirrhosis, all the way to patients with compensated cirrhosis," said Fred Poordad, M.D., vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. "This approval helps achieve physicians' goals of delivering effective options for a broad range of patients."
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.
Approval of MAVYRET follows an FDA-granted Breakthrough Therapy Designation for the treatment of GT1 HCV patients who were not cured with prior DAA therapy, as well as Priority Review. According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of therapies for serious or life-threatening conditions, which may offer substantial improvement over available therapies.
AbbVie's pan-genotypic regimen was also recently granted marketing authorization by the European Commission. AbbVie's treatment is now licensed for use in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
*Ipsos Healthcare HCV Monitor, 2017. New York, NY: Ipsos in North America. ©Ipsos 2017, all rights reserved.
**Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.
ⱡBased on IMS Dx (Oct. 2016) distribution of 15.7% Renal patients in diagnosed population applied to ~3.4M HCV prevalence population of all major HCV genotypes.
About MAVYRET™ (glecaprevir/pibrentasvir)
MAVYRET™ is approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis C virus (HCV) infection in adults across all major genotypes (GT1-6). MAVYRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100mg), an NS3/4A protease inhibitor, and pibrentasvir (40mg), an NS5A inhibitor, dosed once-daily as three oral tablets, taken with food.
MAVYRET is an 8-week, pan-genotypic option for patients without cirrhosis and who are 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 prior treatment experience to either a protease inhibitor or NS5A inhibitor (but not both), and in patients with limited treatment options, such as those with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV. MAVYRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.
Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors.
Full prescribing information can be found here.
Use and Important Safety Information
USE
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 FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including the Patient Information.
If people cannot afford their medication, they should contact www.pparx.org for assistance.
About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.
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).
2 IMS Health. IMS Dx/LRx. December 2016. (©IMS Health Inc., all rights reserved).
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