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ROCHE Launches XOFLUZA, A Single-Dose Treatment for Influenza in Malaysia

Roche (Malaysia) Sdn Bhd today launched XOFLUZA (baloxavir marboxil), a single-dose oral medicine approved in Malaysia for the treatment of acute, uncomplicated influenza, or flu in people 12 years of age and older.

Flu is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. It can affect anyone and can be deadly, especially for those who are vulnerable to complications.

Globally, annual epidemics result in 3 to 5 million cases of severe disease, millions of hospitalisations and up to 650,000 deaths worldwide. In 2006, The World Bank estimated that a more virulent flu pandemic (1918 – 1919 flu) could kill 71 million people worldwide and infect hundreds of millions.

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The impact of the flu is often underestimated and there is an unmet need for safe and effective flu treatment options.

“Flu can be easily confused with other respiratory illnesses, such as the common cold. This is because some milder symptoms, for example, a cough, nasal discharge and sore throat, are similar. However, the flu is characterised by more severe symptoms affecting the whole body (systemic) such as fever, muscle pain and generally feeling unwell. It has the potential to cause a variety of complications, ranging from sinus or ear infections to more severe complications such as pneumonia.

Symptoms of influenza include sudden onset of fever, cough (usually dry), headache, muscle and joint pain, sore throat and a runny nose. The symptoms usually start 24 to 48 hours after infection and last up to eight days. Most adults are contagious one day before their symptoms start and remain contagious up to seven days after becoming sick,” said Dr Petrick @ Ramesh K. Periyasamy, Consultant in Internal Medicine & Infectious Diseases, Head of Infectious Diseases Unit, Hospital UKM at the launch of XOFLUZA.

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XOFLUZA, an oral medicine with its novel mechanism of action, blocks a subunit of the viral polymerase, an enzyme within the flu virus, thus stopping viral replication early in the influenza life cycle, including influenza A & B, which are becoming resistant to commonly prescribed flu treatments.

Unlike other currently available antiviral treatments, XOFLUZA interferes with the ability of the flu virus to multiply, while the older drugs interfere with the ability of the flu virus to spread within the body6.

Following a multicentre, randomised, double-blind, placebo-controlled study, Phase III CAPSTONE-1, involving 1,436 people age 12 and older, to evaluate the efficacy and safety of XOFLUZA, researchers found that taking XOFLUZA, as opposed to Oseltamivir or a placebo, demonstrated better outcomes.

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Patients on XOFLUZA had significantly reduced flu symptoms. For example, at the one-day mark, 90% of patients on Oseltamivir were still positive for influenza whereas only 50% of patients on XOFLUZA carried detectable virus. Virus production in XOFLUZA patients also ceased after 24 hours while it continued for Oseltamivir and placebo patients for 72 and 96 hours respectively. XOFLUZA was well-tolerated and had a numerically lower overall incidence of adverse events (20.7%) reported compared with placebo (24.6%).

XOFLUZA will be an attractive treatment option because it can stop viral shedding (virus released from the body) after only 24 hours and thus, able to limit transmission and help contain outbreaks. Another major benefit is that XOFLUZA treatment involves exactly one dose, making it more convenient for patient compliance when compared with Oseltamivir’s five-day regimen of two doses per day.

Commenting on the launch of XOFLUZA in Malaysia, Dr Charles Li, Medical and Regulatory Director, Roche Malaysia, said, “Building on our long heritage in flu treatment, Roche is now able to offer the public a clinically-evidenced antiviral medicine with new mechanisms of actions to prevent and treat flu effectively.

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XOFLUZA marks the innovation in flu medicine with a special proposed mechanism of action approved by the US Food and Drug Administration (FDA) in nearly 20 years. It affirms Roche’s ongoing commitment to address the unmet need in this area and improve the landscape in infectious diseases which are a major cause of death and illness worldwide.

“As XOFLUZA ushers in a new chapter in flu treatment with its ‘One and Done’ treatment option with convenience of dosing, efficacy and resistance, Roche Malaysia has launched an awareness campaign, ‘Axe The Flu’ to educate the Malaysian public on the disease. Recognising the symptoms of flu early is key to effective treatment and prevention of the virus spreading. If patients see their doctors within 48 hours of symptom onset, one dose of XOFLUZA can significantly reduce the duration of flu symptoms,” he concluded.

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Globally, Roche also remains actively engaged and continues to support WHO’s Pandemic Influenza Preparedness Framework s through its antiviral treatment.

XOFLUZA was first approved in 2018 in Japan and the US and has since gained approval in several other countries. While robust clinical evidence has demonstrated the benefit of XOFLUZA in several populations (otherwise-healthy, high-risk, children) and treatment settings (symptomatic flu, post-exposure prophylaxis or post exposure to the virus), XOFLUZA is being further studied in a phase III development programme, including children under the age of one and severely ill, hospitalised people with flu, as well as to assess the potential to reduce transmission of flu from an infected person to healthy people.

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