F. Hoffmann-La Roche Ltd / Roche announces FDA approval of Xofluza
(baloxavir marboxil) for influenza . Processed and transmitted by West
Corporation. The issuer is solely responsible for the content of this
announcement.
-- First and only single-dose oral medicine approved to treat the flu
-- Xofluza significantly reduced the duration of flu symptoms compared to
placebo
-- First novel proposed mechanism of action to treat the flu in nearly 20
years
Basel, 24 October 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today
announced that the US 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.[1-2] Xofluza
has demonstrated efficacy against a wide range of influenza viruses,
including oseltamivir-resistant strains and avian strains (H7N9, H5N1)
in non-clinical studies.[3-5]
"Xofluza is the first new flu medicine with a novel proposed mechanism
of action approved in nearly 20 years, and we're excited to offer a
convenient treatment option that reduces flu symptoms by more than a day
with a single oral dose," said Sandra Horning, MD, Roche's 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."
The flu is one of the most common, yet serious, infectious diseases,
representing a significant threat to public health. Globally, annual
epidemics result in 3 to 5 million cases of severe disease, millions of
hospitalisations and up to 650,000 deaths worldwide. [6-9]
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.[10] 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
6 September 2018 issue of the New England Journal of Medicine
https://www.nejm.org/doi/full/10.1056/NEJMoa1716197 .[10]
About CAPSTONE-1[10]
CAPSTONE-1 was a phase III multicentre, randomised, double-blind,
placebo-controlled study that evaluated the efficacy and safety of
Xofluza in 1,436 people age 12 and older in the US 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 hours).
The most common adverse events reported were diarrhoea (3.0%),
bronchitis (2.6%), nausea (1.3%) and sinusitis (1.1%), and all of these
adverse events occurred at a lower frequency than placebo. The study was
conducted in the US and Japan by Shionogi & Co., Ltd.
About Xofluza (baloxavir marboxil)
Xofluza is a first-in-class, single-dose oral medicine with a novel
proposed mechanism of action that demonstrated efficacy in a wide range
of influenza viruses, including oseltamivir-resistant strains and avian
strains (e.g. H7N9, H5N1) in non-clinical trials.[3-5] 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.[1,2]
Roche 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 Centers for Disease
Control and Prevention (CDC), met the study's primary objective and
showed superior efficacy in the primary endpoint of time to improvement
of influenza symptoms versus placebo.[11] Xofluza will also be further
studied in a phase III development programme including paediatric
populations, post-exposure prophylaxis and severely ill hospitalised
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 commercialised globally in collaboration with the Roche
Group (which includes Genentech in the US). 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 was approved in February 2018 by the Japanese Ministry of Health,
Labour and Welfare for the treatment of influenza types A and B in adult
and paediatric patients, and is being commercialised in Japan and
marketed under the brand name Xofluza (R)
About Roche in influenza
Influenza, or flu, is one of the most common, yet serious, infectious
diseases, representing a significant threat to public health. Globally,
annual epidemics result in 3 to 5 million cases of severe disease,
millions of hospitalisations and up to 650,000 deaths worldwide.[6-9]
Roche has a long heritage in developing medicines that contribute to
public health. We are committed to bringing innovation in the field of
infectious diseases, including influenza. Tamiflu (oseltamivir) has
made a significant difference both to the treatment of seasonal
influenza as well as in the management of recent pandemics, and we are
proud to have brought this innovative medicine to patients. Although
vaccines are an important first line of defence in preventing the flu,
there is a need for new medical options for prophylaxis and treatment.
Current antiviral drugs have limitations with respect to efficacy,
convenience of dosing, and resistance. Roche is committed to addressing
the unmet need in this area through its agreement with Shionogi & Co.,
Ltd. to develop and commercialise Xofluza.
About Roche in infectious disease
Infectious diseases caused by viral or bacterial pathogens are a major
cause of death and morbidity worldwide, and constitute an ever-growing
medical need. As such, they form a core area of research and development
at Roche, with clinical development programmes focused on Hepatitis B,
influenza and multi-drug resistant bacterial infections. We are
committed to developing medicines that aim to be transformative,
personalised, and accessible.
About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths of
pharmaceuticals and diagnostics under one roof have made Roche the
leader in personalised healthcare - a strategy that aims to fit the
right treatment to each patient in the best way possible.
Roche is the world's largest biotech company, with truly differentiated
medicines in oncology, immunology, infectious diseases, ophthalmology
and diseases of the central nervous system. Roche is also the world
leader in in vitro diagnostics and tissue-based cancer diagnostics, and
a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent,
diagnose and treat diseases and make a sustainable contribution to
society. The company also aims to improve patient access to medical
innovations by working with all relevant stakeholders. Thirty medicines
developed by Roche are included in the World Health Organization Model
Lists of Essential Medicines, among them life-saving antibiotics,
antimalarials and cancer medicines. Moreover, for the tenth consecutive
year, Roche has been recognised as the most sustainable company in the
Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in over
100 countries and in 2017 employed about 94,000 people worldwide. In
2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF
53.3 billion. Genentech, in the United States, is a wholly owned member
of the Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan. For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Shi F, et al. Viral RNA polymerase: a promising antiviral target for
influenza A virus. Curr Med Chem. 2013;20(31):3923-34.
[2] Kawaguchi K, et al. Effects of S-033188, a cap-dependent
endonuclease inhibitor, on influenza symptoms and viral titer: Results
from a phase 2, randomized, double-blind, placebo-controlled study in
otherwise healthy adults with seasonal influenza. Poster presented at
ESWI 2017.
[3] T. Noshi et al. S-033447/S-033188, a Novel Small Molecule Inhibitor
of Cap-dependent Endonuclease of Influenza A and B Virus: In Vitro
Antiviral Activity against Laboratory Strains of Influenza A and B Virus
in Madin-Darby Canine Kidney Cells. Poster presentation at OPTIONS IX,
August 2016.
[4] Taniguchi K, et al. Inhibitory Effect of S-033188, a novel inhibitor
of influenza virus cap-dependent endonuclease, against avian influenza
A/H7N9 virus in vitro and in vivo. Poster presentation at ESWI,
September 2017.
[5] Taniguchi K, et al. Inhibitory Effect of S-033188/S-033447, a novel
inhibitor of influenza virus cap-dependent endonuclease, against highly
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