FDA approves Roche’s Xofluza for Influenza post-exposure prophylaxis

Roche has announced that the U.S. FDA has granted supplemental New Drug Application (sNDA) approval for Xofluza, the first single-dose influenza medicine licensed for post-exposure prophylaxis.

The worlds first single-dose influenza medicine licensed for post-exposure prophylaxis

Xofluza® (baloxavir marboxil) has been officially authorised as a treatment to prevent influenza in individuals 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis).

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development said:

“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza. We’re hopeful that reducing the burden of influenza may help to mitigate the strain on our healthcare system amid the COVID-19 pandemic.”

The phase III BLOCKSTONE study, which was recently published in The New England Journal of Medicine, assessed the post-exposure prophylaxis with single-dose Xofluza.

Compared to placebo, BLOCKSTONE evaluated Xofluza as a preventive medicine for members of the family (adults and children) who were in close contact with those with influenza. A single oral dosage of Xofluza demonstrated a high prophylactic effect on influenza in individuals exposed to an infected household contact.

The number of participants exposed to influenza aged 12 years and older who developed influenza was 1% in the Xofluza-treated group and respectively 13% in the placebo-treated individuals. In this trial, Xofluza was well tolerated and there were no new safety indications observed.

Serese Marotta, Chief Operating Officer at Families Fighting Flu stated:

“The flu is a serious illness that burdens households and sickens millions across the US every year. As we are about to enter a flu season within a global COVID-19 pandemic, we welcome Xofluza as a single-dose flu medicine to be used preventively after exposure to flu.”

Diarrhoea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%) were the most commonly recorded adverse events observed in at least 1% of adult and adolescent influenza participants treated with Xofluza.

Roche is defining a way forward with the FDA for the potential indication of Xofluza as a possible therapy for acute uncomplicated influenza in children who are otherwise healthy (between 1 and 12 years of age) and for the prevention of influenza in the same age range for those exposed to influenza. Xofluza is not licensed for use in this age group at the present. Xofluza was already licensed by the FDA for the treatment of acute uncomplicated influenza in persons 12 years of age and older who have had indications of influenza for no longer than 48 hours and who are otherwise healthy or at high risk of experiencing influenza-related complications.

Despite that, some of the COVID-19 and influenza symptoms may appear identical, entirely distinct viruses cause the two diseases. Xofluza is designed primarily to treat influenza viruses only and is not efficient against SARS-CoV-2.

About the BLOCKSTONE Phase III Trial

BLOCKSTONE is a phase III, double-blind, multicentre, randomised, placebo-controlled, post-exposure prophylaxis study that analysed the effect of a single oral dose of Xofluza® (baloxavir marboxil) in comparison with placebo administered to individuals (adults and children) who were living in the same household with someone diagnosed with influenza confirmed by a rapid influenza test (the ‘index patient’). The trial was performed by Shionogi & Co., Ltd. in Japan during the 2018-2019 influenza season.

The BLOCKSTONE participants with influenza were required to have symptoms for less than 48 hours and to have lived for longer than 48 hours with those diagnosed. As a prevention measure against influenza progress, the participants were randomized to receive a single dose of Xofluza (dose dependent on body weight) or placebo.

About Xofluza® (baloxavir marboxil)

Xofluza is a first-in-line, single-dose oral medicine designed with a novel mechanism of action that has shown effectiveness to a variety of influenza viruses, in non clinical studies, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1). Xofluza is the first in a class of antivirals engineered to block the cap-dependent endonuclease protein, which is responsible for the viral replication.

Xofluza is available in the US and in several other countries for the treatment of influenza types A and B. The novel medicine is authorised in the US for treatment of acute, uncomplicated influenza in individuals 12 years of age and older who are otherwise healthy or at high risk of developing serious influenza-associated complications, and who have been symptomatic for no more than 48 hours. Xofluza is also approved for post-exposure prophylaxis of influenza in people 12 years of age and older following contact with an individual who has influenza. It was the first major antiviral to be approved by the FDA in 20 years.

The efficacy of Xofluza in many populations (otherwise-healthy, high-risk and post-exposure prophylaxis) has been shown by robust clinical data. In a step III development scheme, for children under the age of one (NCT03653364), Xofluza is being further evaluated for the capacity to limit the spread of influenza from an infectious individual to healthy persons (NCT03969212).

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) 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.

About Roche in Influenza

This digitally-colorized, negative-stained transmission electron microscopic (TEM) image depicted a number of Influenza A virions. (Credits: Photo by CDC on Unsplash)

Influenza is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. Globally, seasonal epidemics result in three to five million cases of flu-related severe conditions, millions of hospitalisations and up to 650,000 deaths every year.

Roche has a long legacy in developing drugs dedicated to public health. The company is committed to introducing innovation, particularly in the field of infectious diseases including influenza. Tamiflu® (oseltamivir) has made a huge impact both in the prevention of seasonal influenza and in the control of recent pandemics, and we are happy to have provided patients with this groundbreaking therapy.

There is a need for alternative drug options for prevention (prophylaxis) and recovery, despite that vaccines are an effective first line of protection in avoiding influenza. With regard to efficacy, ease of dosing, and tolerance, most antiviral medications have disadvantages. Trough its deal with Shionogi & Co., Ltd., Roche has shown it is committed to addressing the unmet need in this field.

About Roche

In pharmaceuticals and diagnostics, Roche is a global leader focused on advancing research to better the lives of people. Roche has been the pioneer in tailored healthcare with the integrated capabilities of pharmaceuticals and diagnostics under one roof, a technique that seeks to better suit the right medication for each patient.

Roche is the world’s largest biotech company with differentiated drugs in oncology, immunology, infectious diseases, ophthalmology and central nervous system diseases. Roche is the number one biotech company in the field of in-vitro diagnostics and tissue-based cancer diagnostics. The company is both a global pioneer and a leading player in diabetes control.

Founded in 1896, Roche aims to explore new methods of avoiding, diagnosing and curing diseases and making a sustainable contribution to society. Through collaborating with all key partners, the organization further strives to increase patient access to medical advancements. More than thirty Roche-developed medicines, including life-saving antibiotics, antimalarials and cancer medications, are included in the World Health Organization Model Lists of Essential Medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies 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 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly-owned member of the Roche Group. Roche is also the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

Original Sources: https://www.roche.com/media/releases/med-cor-2020-11-24.htm

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