Phase III Study Showed XOFLUZA (Baloxavir Marboxil) is Effective at Preventing Influenza Infection

June 4, 2019 Off By BusinessWire

– Compared with placebo, XOFLUZA treatment significantly reduced the
likelihood of people developing influenza (flu) after exposure to an
infected household member –

– Data from the Phase III BLOCKSTONE study will be submitted to
health authorities globally –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the Phase III BLOCKSTONE study, conducted by
Shionogi & Co., Ltd., met its primary endpoint showing that people
exposed to a household member with influenza (flu) and treated
preventatively with XOFLUZA™ (baloxavir marboxil) were significantly
less likely to develop the disease compared to those treated with
placebo (1.9% versus 13.6%, p<0.0001). Furthermore, XOFLUZA was well
tolerated with no safety signals identified. Full results from the
BLOCKSTONE study will be presented at an upcoming medical meeting.

“This positive Phase III study adds to robust existing clinical data for
XOFLUZA, and is the first to show that a single treatment with XOFLUZA
reduced the likelihood that people living with an infected household
member would develop the flu,” said Sandra Horning, M.D., chief medical
officer and head of Global Product Development. “Preventing otherwise
healthy people from developing the flu virus will reduce the overall
societal burden of disease, and we look forward to sharing these data
with health authorities around the world.”

XOFLUZA is the first and only one-dose oral medicine approved to treat
the flu, and the first new flu medicine approved by the U.S. Food and
Drug Administration (FDA) with a novel proposed mechanism of action in
nearly 20 years. XOFLUZA is also the only flu treatment with a new
mechanism of action shown to be efficacious in both otherwise healthy
people with the flu (in the CAPSTONE-1 study) and people at high risk of
flu complications (in the CAPSTONE-2 study).

XOFLUZA is currently approved in Japan for the treatment of influenza
types A and B in children, adolescents and adults, and in the U.S. for
the treatment of acute, uncomplicated influenza in people 12 years of
age and older. In addition, the FDA recently accepted a supplemental New
Drug Application (sNDA) for XOFLUZA as a one-dose oral treatment for
people at high risk of complications from the flu, which includes adults
65 years of age or older, or those who have conditions such as asthma,
chronic lung disease, morbid obesity or heart disease – for these people
the flu can be particularly serious or deadly. The FDA is expected to
decide on whether to approve this additional indication by November 4,
2019.

About BLOCKSTONE

BLOCKSTONE is a Phase III, randomized, placebo-controlled, post-exposure
prophylaxis study that evaluated a single dose of XOFLUZA compared with
placebo in household members (adults and children) in Japan who are
living with someone with an influenza infection confirmed by a rapid
influenza diagnostic test (the ‘index patient’). The study was conducted
by Shionogi & Co., Ltd. during the 2018-2019 flu season in Japan.

Participants enrolled in the study were household members of someone who
had been diagnosed with influenza. The participants were randomized to
receive a single dose of XOFLUZA (dose according to body weight) or
placebo as a preventative measure against developing influenza. The
primary endpoint of the study was to evaluate the proportion of
participants who tested positive for the influenza virus and had fever,
and one or more respiratory symptoms between day one and ten.

XOFLUZA showed a significant prophylactic effect on influenza infection
after a single oral dose in people exposed to an infected family member.
The proportion of household members who became symptomatically ill
following infection with flu was significantly lower in those treated
preventively with XOFLUZA compared to those treated with placebo
(proportion of subjects with influenza virus infection, fever and other
influenza symptoms in the 10-day observation period: 1.9% versus 13.6%,
p<0.0001). The incidence of adverse events was 22.2% and 20.5% in
XOFLUZA and placebo respectively. No serious adverse events were
reported for XOFLUZA. Secondary objectives were clinical efficacy,
pharmacokinetics and safety and tolerability.

About XOFLUZA™ (baloxavir marboxil)

XOFLUZA is a first-in-class, one-dose oral medicine with a novel
proposed mechanism of action that has demonstrated efficacy in a wide
range of influenza viruses, including in vitro activity against
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 the cap-dependent endonuclease protein, which is essential
for viral replication.

XOFLUZA is being further studied in a Phase III development program,
including pediatric populations 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
herbal supplements.

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, representing a significant threat to public health. Since
2010, the Centers for Disease Control and Prevention (CDC) estimates
that the flu has resulted annually in 9.3 to 49 million illnesses,
140,000 to 960,000 hospitalizations and 12,000 to 79,000 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 antiviral medicines have limitations with respect to
efficacy, convenience of dosing and resistance. Genentech is committed
to addressing the unmet need in this area through its agreement with
Shionogi & Co., Ltd. to develop and commercialize XOFLUZA.

About Genentech

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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