NORTH CHICAGO, Ill.,
Sept. 26, 2019 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research-based global
biopharmaceutical company, today announced that the U.S. Food and
Drug Administration (FDA) has granted approval
of MAVYRET® (glecaprevir/pibrentasvir)
to shorten the once-daily treatment duration from 12 to 8 weeks in
treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV)
patients across all genotypes (GT1-6). In August 2017, MAVYRET received regulatory approval
in the U.S. as an 8-week, pan-genotypic treatment for
treatment-naïve HCV patients without cirrhosis.
"While over 100,000 patients have been prescribed MAVYRET for
chronic HCV in the US‡, there are still a
significant number of patients that need options," said Janet
Hammond, M.D., Ph.D., vice president, general medicine and virology
therapeutic area, AbbVie. "This approval provides more HCV patients
an option to treat their disease in as little as 8 weeks."
The label expansion was based on data from the Phase
3b EXPEDITION-8 study, a single-arm,
open-label study evaluating the safety and efficacy of MAVYRET in
treatment-naïve adults with GT1-6 chronic HCV and compensated
cirrhosis. In the study, an overall 98 percent (n=335/343) of
patients achieved a sustained virologic response 12 weeks after
treatment (SVR12).1
"With more than 2.3 million people in the United States still living with chronic
HCV, access to shorter-term, 8-week treatment options can help us
move closer to achieving the World Health Organization's goal of
eliminating HCV by 2030," said Robert S.
Brown, Jr., M.D., Gladys and Roland Harriman professor
of medicine, Weill Cornell Medical College.
In EXPEDITION-8, a single relapse out of 336 patients treated
was reported and no patients discontinued treatment due to adverse
events.1,2 The adverse reactions reported in
greater than or equal to 5 percent of compensated cirrhotic
patients (n=343) were fatigue (8%), pruritus (7%), and headache
(6%).1 Data from cohort one
(GT1,2,4,5,6) was presented last year at The Liver
Meeting® 2018 organized by the American Association for
the Study of Liver Diseases (AASLD), and data from cohort two (GT3)
will be presented at an upcoming medical meeting.
About the EXPEDITION-8
Study1,2
EXPEDITION-8 is a single-arm,
open-label, Phase 3b study in
treatment-naïve, GT1-6 chronic HCV patients with compensated
cirrhosis (n=343) who received MAVYRET for 8 weeks.
The primary endpoints are the sustained virologic response 12
weeks after treatment (SVR12) rates in patients across
all genotypes in a per-protocol (PP) and intent-to-treat (ITT)
population versus respective historical SVR12 rates
based on the efficacy of MAVYRET for 12 weeks in treatment-naïve
patients with compensated cirrhosis. The key secondary efficacy
endpoints are the percentages of GT1- 6 patients achieving
SVR12 in a PP and ITT population.
Additional information on the clinical trials for MAVYRET is
available at www.clinicaltrials.gov/.
About
MAVYRET® (glecaprevir/pibrentasvir)1
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 as three tablets
taken at the same time once daily with food.
MAVYRET is an 8-week, pan-genotypic option for treatment-naïve
patients without cirrhosis or with compensated cirrhosis, 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 Information1
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 (hep B)
reactivation: Before starting treatment with MAVYRET, a
doctor will do blood tests to check for hep B infection. If people
have ever had hep B infection, hep B could become active again
during or after treatment for hep C with MAVYRET. Hep B that
becomes 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 hep B 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 or rifampin
What should people tell a doctor before taking
MAVYRET?
- If they have had hep B infection, have liver problems other
than hep C infection, have HIV-1 infection, have had a liver or a
kidney transplant, and all 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 possible side effects of MAVYRET?
- In people who had or have advanced liver problems before
starting treatment with MAVYRET, there is a rare risk of worsening
liver problems, liver failure, and death. Their doctor will
check them for signs and symptoms of worsening liver problems
during treatment with MAVYRET. They should tell their doctor right
away if they have any of the following: nausea; tiredness;
yellowing of the skin or white part of the eyes; bleeding or
bruising more easily than normal; confusion; dark, black, or bloody
stool; loss of appetite; diarrhea; dark or brown (tea-colored)
urine; swelling or pain on the upper right side of the stomach area
(abdomen); sleepiness; vomiting of blood; or lightheadedness.
- 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
AbbVie.com/myAbbVieAssist to learn more.
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.
For more information, please
visit www.abbvie.com/HCV.
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, 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," of
AbbVie's 2017 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.
_________________________________
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*Refers to
patients with Child-Pugh A cirrhosis score.
|
†Liver or kidney
transplant recipients are not eligible for an 8-week
regimen.
|
**Patients who
achieve a sustained virologic response at 12 weeks post treatment
(SVR) are considered cured of hepatitis C.
|
‡Based on retail and non-retail
prescription data from IQVIA week ending
8/11/17-8/2/19.3
|
|
1MAVYRET® tablets
(glecaprevir/pibrentasvir) Prescribing Information. Chicago, U.S.
AbbVie Inc.
|
2 Brown RS, Hezode C, Wang S, et al.
Preliminary Efficacy and Safety of 8-Week Glecaprevir/Pibrentasvir
in Patients with HCV Genotype 1–6 Infection and Compensated
Cirrhosis: The EXPEDITION-8 Study. Presented at The Liver
Meeting®, the Annual Meeting of the American Association for the
Study of Liver Diseases (AASLD) in San Francisco, U.S., November
13, 2018.
|
3 Data on file. AbbVie Inc. IQVIA.
National Prescription Audit (NPA) week ending 8/11/2017 to week
ending 8/2/2019, Weekly Sales Perspective (WSP) and Longitudinal
Prescription Claims (LRx) week ending 8/4/2017 to week ending
7/26/2019. August 2019. (IQVIA, all rights reserved).
|
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