South San Francisco, CA -- October 17, 2019 -- Genentech, a member
of the Roche Group, today announced that the U.S. Food and Drug Administration
(FDA) has approved a supplemental New Drug Application (sNDA) for Xofluzaâ„¢
(baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or
flu, in people 12 years of age and older who have been symptomatic for no more
than 48 hours and who are at high risk of developing flu-related complications.
Xofluza is a first-in-class, one-dose oral medicine with a novel proposed
mechanism of action that inhibits polymerase acidic endonuclease, an enzyme
essential for viral replication.
"With the flu season rapidly approaching, we can now offer
Xofluza as the first and only FDA-approved treatment option indicated
specifically for those at high risk of flu complications," said Levi
Garraway, M.D., Ph.D., chief medical officer and head of Global Product
Development. “People with chronic conditions such as asthma, heart disease and
diabetes are at higher risk of developing serious complications from the flu,
so it is critical that these patients speak with their healthcare providers
about possible treatment at the first signs and symptoms of the disease.â€
The flu has the potential to cause a variety of complications,
ranging from sinus or ear infections to more serious complications such as
pneumonia. This expanded indication for Xofluza was approved based on results
from the Phase III CAPSTONE-2 study of a single dose of 40 mg or 80 mg of
Xofluza compared to oseltamivir (75 mg twice daily for five days), or placebo
in people 12 years of age or older who met CDC criteria for being at high risk
of complications from the flu. Xofluza significantly reduced the time to
improvement of flu symptoms compared to placebo, including in people infected
with the flu type B virus. Adverse events reported in at least 1% of adult and
adolescent subjects treated with Xofluza included diarrhea (3%), bronchitis
(3%), nausea (2%), sinusitis (2%) and headache (1%).
Xofluza is currently approved in several countries for the
treatment of flu types A and B. In October 2018, Xofluza was first approved by
the FDA for the treatment of acute, uncomplicated flu in otherwise healthy
people 12 years of age and older who have been symptomatic for no more than 48
hours, representing the first new antiviral to treat the flu in the U.S. in 20
years.
About CAPSTONE-2
CAPSTONE-2 is a Phase III, multicenter, randomized, double-blind
study that evaluated a single dose of Xofluza compared with placebo and
oseltamivir in people 12 years of age or older who are at a high risk of
complications from the flu. The Centers for Disease Control and Prevention
(CDC) defines people at high risk of serious flu complications as those who
have conditions such as asthma, chronic lung disease, diabetes, heart disease,
morbid obesity or adults 65 years of age or older. The study was conducted
globally by Shionogi & Co., Ltd.
Participants enrolled in the study were randomly assigned to
receive a single dose of 40 mg or 80 mg of Xofluza, placebo or 75 mg of
oseltamivir twice a day for five days. The primary objective of the study was
to evaluate the efficacy of a single dose of Xofluza compared with placebo by
measuring the time to improvement of flu symptoms. Key findings from the study
found that:
Xofluza significantly reduced the time to improvement of flu
symptoms versus placebo in people at high risk of complications from the flu
(median time 73 hours versus 102 hours; p<0.001).
Similar efficacy results were seen between Xofluza and oseltamivir
in relation to duration of symptoms (median time 73 hours versus 81hours).
In subjects infected with type B virus, the median time to
improvement of flu symptoms was shorter in the Xofluza group compared to the
placebo group (75 hours versus 101 hours respectively).
Adverse events reported in at least 1% of adult and adolescent
subjects treated with Xofluza included diarrhea (3%), bronchitis (3%), nausea
(2%), sinusitis (2%) and headache (1%). Xofluza was well-tolerated and no new
safety signals were identified.
About Xofluza â„¢ (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 children under the age of one (NCT03653364), severely ill,
hospitalized people with the flu (NCT03684044), as well as to assess the
potential to reduce transmission of the flu from an infected person to healthy
people (NCT03969212).
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 and who are otherwise healthy or at high risk of
developing flu-related complications.
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).
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.
Other 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.
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