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Biopharmaceuticals Regulatory

 News Release - January 31, 2020

AbbVie Receives Positive CHMP Opinion for MAVIRET(R) (glecaprevir/pibrentasvir) to Shorten Treatment Duration to Eight Weeks in Genotype 3, Treatment-Na´ve Patients with Chronic Hepatitis C and Compensated Cirrhosis

If approved by the European Commission (EC), MAVIRET will be the only pan-genotypic (GT1-6) 8-week treatment option for treatment-na´ve, chronic hepatitis C (HCV) patients, without cirrhosis or with compensated cirrhosis

Final European Commission decision expected in 2020


NORTH CHICAGO, Ill., Jan. 31, 2020 -- (Healthcare Sales & Marketing Network) -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a change to the marketing authorization for MAVIRET« (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-na´ve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection. MAVIRET is currently indicated as an 8-week, pan-genotypic (GT1-6), once-daily regimen for treatment-na´ve HCV patients without cirrhosis, and as an 8-week, once-daily regimen for treatment-na´ve GT 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis.1* If approved by the European Commission (EC), MAVIRET will be the only 8-week treatment option for treatment-na´ve chronic HCV patients, without cirrhosis or with compensated cirrhosis, regardless of genotype.*

"The HCV treatment pathway can be a complicated journey for the millions of patients affected by the disease," said Janet Hammond M.D., Ph.D., vice president, general medicine and virology therapeutic area, AbbVie. "Today's positive CHMP opinion for MAVIRET moves us further toward our goal of providing an effective 8-week therapeutic option with the potential to simplify the treatment journey for the majority of people living with HCV, regardless of disease genotype."

The CHMP positive opinion is supported by data from the Phase 3b EXPEDITION-8 study, which showed that with 8 weeks of MAVIRET, 97.7 percent (n=335/343) of GT1- 6 patients achieved a sustained virologic response 12 weeks after treatment (SVR12) (ITT). For patients with GT3, the SVR12 rate was 95.2% (n= 60/63) (ITT). To date, one virologic failure has been reported in these patients and no patients have discontinued treatment due to adverse events. Adverse events (frequency >5%) reported in the study include pruritus (8%), fatigue (9%), headache (8%) and nausea (6%). Six serious adverse events (2%) occurred during the study, none of which were deemed to be related to glecaprevir/pibrentasvir. No new safety signals were identified in this study.2

The Phase 3b EXPEDITION-8 study evaluated the safety and efficacy of MAVIRET in treatment-na´ve chronic HCV patients with compensated cirrhosis across all major genotypes (GT1-6). The results have been reported for GT1, 2, 3, 4, 5, and 6 (n=343) patients.2

"Successfully treating people with HCV has historically been challenging, in part because of the length of the treatment duration and the need for additional testing to determine the patient's disease genotype and fibrosis stage to match them with the most appropriate therapy," said Stefan Zeuzem, M.D., chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany. "A clinically validated HCV therapeutic option that can reduce both the treatment timeframe and diagnostic burden may help providers treat more patients and reduce how many are lost to follow-up, ultimately potentially helping to hasten elimination of the disease globally."

About the EXPEDITION-8 Study2

EXPEDITION-8 is a single-arm, open-label, Phase 3b study in treatment-na´ve, GT1-6 chronic HCV patients with compensated cirrhosis (n=343) who received MAVIRET for 8 weeks.

The primary efficacy endpoints were SVR12 in patients with GT1, 2, 4, 5, and 6 in a per-protocol (PP) and intent-to-treat (ITT) population versus historical SVR12 rates based on the efficacy of MAVIRET for 12 weeks in treatment-na´ve patients with compensated cirrhosis. The key secondary efficacy endpoints were the percentages of GT1-6 patients achieving SVR12 in a PP and ITT population.

Additional information on the clinical trials for MAVIRET is available at www.clinicaltrials.gov/.

About MAVIRET« (glecaprevir/pibrentasvir)1

MAVIRET is approved in the European Union for the treatment of chronic hepatitis C virus (HCV) infection in adults and adolescents aged 12 to <18 years across all major genotypes (GT1-6). MAVIRET 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.

MAVIRET is an 8-week, pan-genotypic (GT 1-6) option for patients without cirrhosis and who are new to treatment and for GT1, 2, 4, 5 and 6 patients who are new to treatment with compensated cirrhosis*. The recommended treatment duration for treatment-na´ve, compensated cirrhotic GT3 HCV patients is 12 weeks. MAVIRET is also approved as a treatment for patients with specific treatment challenges, including those with compensated cirrhosis across all major genotypes, and those who previously had limited treatment options, such as patients with severe chronic kidney disease (CKD) or those with genotype 3 chronic HCV infection. MAVIRET is a pan-genotypic treatment approved for use in patients across all stages of CKD.

MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in patients with moderate hepatic impairment (Child-Pugh B).

Glecaprevir (GLE) was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.

EU Indication

MAVIRET is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and adolescents aged 12 to <18 years old.

Important EU Safety Information

Contraindications:

MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers, such as rifampicin, carbamazepine, St. John's wort, phenobarbital, phenytoin, and primidone.

Special warnings and precautions for use:

Hepatitis B virus reactivation

Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should be performed in all patients before initiation of treatment.

Hepatic impairment

MAVIRET is not recommended in patients with moderate hepatic impairment (Child-Pugh B).

Patients who failed a prior regimen containing an NS5A- and/or an NS3/4A-inhibitor MAVIRET is not recommended for the re-treatment of patients with prior exposure to NS3A/4A and/or NS5A-inhibitors.

Use in diabetic patients

Diabetics may experience improved glucose control and potential symptomatic hypoglycaemia after initiating HCV direct acting antiviral treatment. Glucose levels should be closely monitored, particularly within the first 3 months of treatment.

Adverse Reactions

Most common (≥10%) adverse reactions for MAVIRET were headache and fatigue.

This is not a complete summary of all safety information. See MAVIRET full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie

AbbVie is a global, research and development-based 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, LinkedIn or Instagram.

Forward-Looking Statements

Some statements in this news release are, or may be considered, 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, competition from other products, challenges to intellectual property, 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," of AbbVie's 2018 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 MAVIRET« tablets (glecaprevir/pibrentasvir) Summary of product characteristics. Maidenhead, UK. AbbVie, Ltd.

2 Brown RS et al. Glecaprevir/pibrentasvir for 8 weeks in treatment-na´ve patients with chronic HCV genotypes 1ľ6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol (2019)

* The recommended duration of MAVIRET is 12 weeks in liver or kidney transplant recipients with or without cirrhosis


Source: AbbVie

Issuer of this News Release is solely responsible for its content.
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