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SOUTH SAN FRANCISCO, Calif .– (BUSINESS WIRE) – Genentech, member of the Roche group (SIX: RO, ROG, OTCQX: RHHBY),
announced today that the BLOCKSTONE Phase III study, conducted by
Shionogi & Co., Ltd., met its primary evaluation criterion, showing that
exposed to a family member with influenza and treated
as a precaution 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). In addition, XOFLUZA was well
tolerated without identified safety signals. Full results of the
The BLOCKSTONE study will be presented at a future medical meeting.
"This positive Phase III study adds to the strong existing clinical data for
XOFLUZA, and is the first to show that only one treatment by XOFLUZA
reduces the likelihood that people living with an infected household
member would develop the flu, "said Sandra Horning, MD, chief of medicine
responsible and responsible for global product development. "Prevent otherwise
healthy people to develop the flu virus will reduce the
societal burden of disease, and we look forward to sharing this data
with health authorities around the world. "
XOFLUZA is the first and only oral drug at a dose approved to treat
influenza, and the first new influenza drug approved by the United States Food and
Drug Administration (FDA) with a new mechanism of action proposed in
almost 20 years old. XOFLUZA is also the only flu treatment with a new
mechanism of action shown to be effective both otherwise healthy
people with influenza (in the CAPSTONE-1 study) and people at high risk of
Influenza 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 United States for
treatment of uncomplicated acute influenza in 12 year olds
age and older. In addition, the FDA has recently accepted a new supplement
Drug Application (sNDA) for XOFLUZA as an oral treatment a dose for
people at high risk of influenza complications, including adults
65 years or older, or those with conditions such as asthma,
chronic lung disease, morbid obesity or heart disease – for these people
the flu can be particularly serious or deadly. FDA should
decide whether to approve this additional indication by 4 November,
2019.
About BLOCKSTONE
BLOCKSTONE is a randomized, placebo-controlled phase III post-exposure treatment.
prophylaxis study evaluating a single dose of XOFLUZA compared to
placebo among household members (adults and children) in Japan who are
living with a person with an influenza infection confirmed by a
Diagnostic test for influenza (the "patient index"). The study was conducted
Shionogi & Co., Ltd. during the 2018-2019 influenza season in Japan.
The study participants were household members of someone who
had been diagnosed with the flu. Participants were randomized to
receive a single dose of XOFLUZA (dose based on body weight) or
placebo as a preventive measure against the development of influenza. the
The main criterion of the study was to evaluate the proportion of
participants who tested positive for the influenza virus and who had fever,
and one or more respiratory symptoms between the first and the tenth day.
XOFLUZA has shown 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 contracted a symptomatic illness
following an influenza infection was significantly lower among
preventatively with XOFLUZA compared to those treated with a placebo
(proportion of people infected with the influenza virus, fever and other
flu-like symptoms during the 10-day observation period: 1.9% vs. 13.6%,
p <0.0001). The incidence of adverse events was 22.2% and 20.5% at
XOFLUZA and a placebo respectively. No serious adverse events have been reported
reported for XOFLUZA. Secondary objectives were clinical effectiveness,
pharmacokinetics, safety and tolerance.
About XOFLUZA ™ (Baloxavir marboxil)
XOFLUZA is a single-dose oral medication with a new medicine.
proposed mechanism of action that has demonstrated its effectiveness in a broad
range of influenza viruses, including in vitro activity against
Oseltamivir-resistant strains and avian (H7N9, H5N1) strains at
non-clinical studies. Unlike other antivirals currently available
treatments, XOFLUZA is the first of a new clbad of antivirals designed
to inhibit the cap-dependent endonuclease protein, which is essential
for viral replication.
XOFLUZA is under study as part of a Phase III development program,
including pediatric and critically ill populations, hospitalized
with the flu, as well as evaluate the potential for reduction
transmission in otherwise healthy people.
XOFLUZA was discovered by Shionogi & Co., Ltd. and continues
developed and marketed globally in collaboration with Roche
Group (which includes Genentech in the US) and Shionogi & Co., Ltd.
Under the terms of this agreement, Roche holds the worldwide rights to
XOFLUZA excluding Japan and Taiwan, which will be kept exclusively
by Shionogi & Co., Ltd.
Indication XOFLUZA U.S.
XOFLUZA is a prescribed medicine used to treat influenza (flu) in
people 12 years and older who have had flu symptoms for not longer
less than 48 hours.
It is not known if XOFLUZA is safe and effective in younger children
under 12 years old or weighing less than 40 kg (88 pounds).
Limits of use: Influenza viruses
change over time, and factors such as virus type or subtype,
the emergence of resistance or changes in viral virulence could decrease the
clinical benefit of antiviral drugs. Examine the information available on
Drug susceptibility profiles for circulating influenza strains
to decide to use XOFLUZA.
Important safety information
Do not take XOFLUZA if you are allergic to baloxavir
marboxil or any of the ingredients of XOFLUZA.
Before taking XOFLUZA, tell your health care provider about all
your medical conditions, including if you:
-
are pregnant or planning to become pregnant We do not know if XOFLUZA
can harm your unborn baby. -
badfeed or plan to badfeed. We do not know if XOFLUZA
pbad into your bad milk.
Talk to your health care provider about all the medications you take,
prescription and over-the-counter medications, vitamins and
herbal supplements.
Talk to your health care provider before receiving a live flu vaccine
after taking XOFLUZA.
Take XOFLUZA with or without food. Do not take XOFLUZA with dairy products
calcium-enriched drinks, laxatives, antacids or
supplements containing iron, zinc, selenium, calcium or magnesium.
The most common side effects are diarrhea, bronchitis,
nausea, cold symptoms (nasopharyngitis) and headaches.
XOFLUZA is not effective in the treatment of infections other than influenza.
Other types of infections can have symptoms such as those of the flu or
occur at the same time as influenza and may require different types of treatment. Say
your health professional if you feel worse or develop new symptoms
during or after treatment with XOFLUZA or if your flu symptoms do not go away.
start to get better
Please see the complete XOFLUZA Prescribe
Information for complete security information.
We encourage you to report adverse reactions to Genentech by calling
1-888-835-2555 or the FDA by visiting http://www.fda.gov/medwatch
or by calling 1-800-FDA-1088.
About Genentech in the flu
Influenza, or flu, is one of the most common, but serious, infectious diseases.
diseases, posing a significant threat to public health. Since
2010, Centers for Disease Control and Prevention (CDC) estimates
that the flu has caused between 9.3 and 49 million diseases each year,
140,000 to 960,000 hospitalizations and 12,000 to 79,000 deaths.
Although vaccines are an important first line of defense to prevent
influenza, new medical options for prophylaxis and
treatment. Current antiviral drugs have limitations with respect to
efficiency, convenience of dosage and resistance. Genentech pledges
meet the unmet needs in this area through its agreement with
Shionogi & Co., Ltd. to develop and market XOFLUZA.
About Genentech
Founded more than 40 years ago, Genentech is one of the leaders in biotechnology.
company that discovers, develops, manufactures and markets
drugs to treat patients with serious and life-threatening medical conditions
conditions. The company, a member of the Roche Group, has its head office
in southern San Francisco, California. For more information on the
company, please visit http://www.gene.com.
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