First and only single-dose oral medicine approved to treat the flu
XOFLUZA significantly reduced the duration of flu symptoms compared
First novel proposed mechanism of action to treat the flu in
nearly 20 years
SOUTH SAN FRANCISCO, Calif.(BUSINESS WIRE)
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the U.S. Food and Drug Administration (FDA) has
approved XOFLUZA? (baloxavir marboxil) for the treatment of
acute, uncomplicated influenza, or flu, in people 12 years of age and
older. XOFLUZA is a first-in-class, single-dose oral medicine with a
novel proposed mechanism of action that inhibits polymerase acidic
endonuclease, an enzyme essential for viral replication. XOFLUZA has
demonstrated efficacy against a wide range of influenza viruses,
including oseltamivir-resistant strains and avian strains (H7N9, H5N1)
in non-clinical studies.
XOFLUZA is the first new flu medicine with a novel proposed mechanism
of action approved in nearly 20 years, and were excited to offer a
convenient treatment option that reduces flu symptoms by more than a day
with a single oral dose, said Sandra Horning, M.D., chief medical
officer and head of Global Product Development. If patients see their
doctors within 48 hours of symptom onset, one dose of XOFLUZA can
significantly reduce the duration of flu symptoms.
Each year, an estimated 3-11 percent of the U.S. population gets the
flu, and it can be very serious, resulting in hospitalization or even
death. Since 2010, the Centers for Disease Control and Prevention (CDC)
estimates that the flu has resulted annually in 9.2 to 35.6 million
illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000
The devastation of last year's flu season underscores the need for new
treatment options beyond currently available antivirals or
over-the-counter medications, said Serese Marotta, chief operating
officer, Families Fighting Flu. While the flu vaccine is a crucial
first step in preparing for flu season and preventing illness, XOFLUZA
is an important new treatment option if you do get sick.
XOFLUZA was approved based on results from the Phase III CAPSTONE-1
study of a single dose of XOFLUZA compared with placebo or oseltamivir
75 mg, twice daily for five days, in otherwise healthy people with the
flu, as well as results from a placebo-controlled Phase II study in
otherwise healthy people with the flu. XOFLUZA significantly reduced the
duration of flu symptoms compared to placebo, and demonstrated similar
efficacy compared to oseltamivir. In clinical trials, XOFLUZA was safe
and well-tolerated with a side effect profile similar to placebo. The
CAPSTONE-1 and Phase II study results were recently published in the
September 6, 2018 issue of the New
England Journal of Medicine.
XOFLUZA will be available across the U.S. in the coming weeks. Genentech
is committed to helping people who are prescribed XOFLUZA get access to
the medicine and will be offering a coupon for all eligible patients.
Please visit http://www.xofluza.com
or call 1-855-XOFLUZA (1-855-963-5892) for more information.
CAPSTONE-1 was a Phase III multicenter, randomized, double-blind,
placebo-controlled study that evaluated the efficacy and safety of
XOFLUZA in 1,436 people age 12 and older in the United States (U.S.) and
Japan. The primary endpoint of the study was time to alleviation of
symptoms. The study found the following results:
XOFLUZA met its primary endpoint compared to placebo:
Significantly reduced the duration of flu symptoms by more than
one day (median time 54 hours versus 80 hours; p<0.001);
Similar efficacy results were seen between XOFLUZA and oseltamivir in
relation to duration of symptoms (median time 54 hours versus 54
The most common adverse events reported were diarrhea (3.0 percent),
bronchitis (2.6 percent), nausea (1.3 percent) and sinusitis (1.1
percent), and all of these adverse events occurred at a lower frequency
than placebo. The study was conducted in the U.S. and Japan by Shionogi
& Co., Ltd.
XOFLUZA is a first-in-class, single-dose oral medicine with a novel
proposed mechanism of action that has demonstrated efficacy in a wide
range of influenza viruses, including oseltamivir-resistant strains and
avian strains (H7N9, H5N1) in non-clinical studies. Unlike other
currently available antiviral treatments, XOFLUZA is the first in a new
class of antivirals designed to inhibit polymerase acidic endonuclease,
an enzyme essential for viral replication.
Genentech recently announced that the global Phase III CAPSTONE-2 study
assessing the safety and efficacy of XOFLUZA in people at high risk of
complications from the flu, as defined by the CDC, met the study's
primary objective and showed superior efficacy in the primary endpoint
of time to improvement of influenza symptoms versus placebo. XOFLUZA
will also be further studied in a Phase III development program
including pediatric populations, post-exposure prophylaxis and severely
ill hospitalized people with influenza, as well as to assess the
potential to reduce transmission in otherwise healthy people.
XOFLUZA was discovered by Shionogi & Co., Ltd. and is being further
developed and commercialized globally in collaboration with the Roche
Group (which includes Genentech in the U.S.) and Shionogi & Co., Ltd.
Under the terms of this agreement, Roche holds worldwide rights to
XOFLUZA excluding Japan and Taiwan, which will be retained exclusively
by Shionogi & Co., Ltd.
XOFLUZA U.S. Indication
XOFLUZA is a prescription medicine used to treat the flu (influenza) in
people 12 years of age and older who have had flu symptoms for no more
than 48 hours.
It is not known if XOFLUZA is safe and effective in children younger
than 12 years of age or weighing less than 88 pounds (40 kg).
Limitations of Use: Influenza viruses
change over time, and factors such as the virus type or subtype,
emergence of resistance or changes in viral virulence could diminish the
clinical benefit of antiviral drugs. Consider available information on
drug susceptibility patterns for circulating influenza virus strains
when deciding whether to use XOFLUZA.
Important Safety Information
Do not take XOFLUZA if you are allergic to baloxavir marboxil or
any of the ingredients in XOFLUZA.
Before you take XOFLUZA, tell your healthcare provider about all of
your medical conditions, including if you:
are pregnant or plan to become pregnant. It is not known if XOFLUZA
can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if XOFLUZA
passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins and
Talk to your healthcare provider before you receive a live flu vaccine
after taking XOFLUZA.
Take XOFLUZA with or without food. Do not take XOFLUZA with dairy
products, calcium-fortified beverages, laxatives, antacids or oral
supplements containing iron, zinc, selenium, calcium or magnesium.
The most common side effects are diarrhea, bronchitis, nausea,
common cold symptoms (nasopharyngitis) and headache.
XOFLUZA is not effective in treating infections other than influenza.
Other kinds of infections can have symptoms like those of the flu or
occur along with the flu and may need different kinds of treatment. Tell
your healthcare provider if you feel worse or develop new symptoms
during or after treatment with XOFLUZA or if your flu symptoms do not
start to get better.
Please see the XOFLUZA full Prescribing
Information for complete safety information.
You are encouraged to report side effects to Genentech by calling
1-888-835-2555 or to the FDA by visiting http://www.fda.gov/medwatch
or calling 1-800-FDA-1088.
About Genentech in influenza
Influenza, or flu, is one of the most common yet serious infectious
diseases. Since 2010, the CDC estimates that the flu has resulted
annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000
hospitalizations and 12,000 to 80,000 deaths. Although vaccines are an
important first line of defense in preventing the flu, there is a need
for new medical options for prophylaxis and treatment. Current
treatments including existing vaccines and antiviral drugs have
limitations as flu viruses are constantly changing and new antiviral
medicines are necessary. Genentech is committed to addressing the unmet
need in this area through its agreement with Shionogi & Co., Ltd. to
develop and commercialize XOFLUZA.
Founded more than 40 years ago, Genentech is a leading biotechnology
company that discovers, develops, manufactures and commercializes
medicines to treat patients with serious and life-threatening medical
conditions. The company, a member of the Roche Group, has headquarters
in South San Francisco, California. For additional information about the
company, please visit http://www.gene.com.
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Heather Gloe, 650-467-6800
Jocelyn Ashford, 650-866-7579
Loren Kalm, 650-225-3217
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