Wednesday, Oct 24, 2018

Genentech Announces FDA Approval of XOFLUZA (Baloxavir Marboxil) for Influenza

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

South San Francisco, CA -- October 24, 2018 --

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 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, 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 deaths.

“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.

About CAPSTONE-1

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 hours).

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.

About XOFLUZA

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 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. 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.

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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