Roche Holding AG’s RHHBY member, Genentech announced that a phase III study investigating its new single-dose oral flu medicine, Xofluza (baloxavir marboxil) in children met the primary endpoint. The MINISTONE-2 study demonstrated that Xofluza was well tolerated in otherwise healthy kids aged between one and less than 12 years old with the flu.
The study also showed that Xofluza is comparable to Roche’s older flu medicine, Tamiflu, (oseltamivir) in reducing the duration of flu symptoms, including fever. Tamiflu, to be taken twice daily for five days, has lost patent protection and generic versions are available.
Xofluza is presently marketed in the United States for the treatment of acute, uncomplicated influenza in people 12 years of age and older. It is not approved for use in children younger than 12 years of age. It is approved in Japan and several other countries to treat influenza types A and B in children, adolescents and adults. Roche developed Xofluza in partnership with Japan’s Shionogi.
Roche’s shares have risen 14.3% this year so far compared with an increase of 2.9% for the industry.
Children are usually at a higher risk of catching flu and approximately one in three children develop flu every year. Moreover, they are more contagious than adults and sometimes develop complications such as breathing problems and pneumonia. If approved to treat flu in children, Xofluza could be a convenient treatment option as it is the only approved single-dose oral medicine to treat flu.
Meanwhile, Xofluza is being evaluated in several studies to expand its eligible patient population including MINISTONE-1, which is evaluating the safety and efficacy of Xofluza in infants under the age of one.
In fact, in March, the FDA had accepted a supplemental new drug application for Xofluza for the treatment of influenza in people at high risk of complications based on data from the CAPSTONE-2 study. The FDA is expected to make a decision on approval by Nov 4, 2019. Xofluza is also being evaluated in phase III studies in severely ill, hospitalized people with flu as well as to assess the potential to reduce transmission in otherwise healthy people.
Popular influenza vaccines in the market are Sanofi’s SNY Fluzone Quadrivalent, Glaxo’s GSK Fluarix Quadrivalent and AstraZeneca’s AZN FluMist Quadrivalent
Roche currently carries a Zacks Rank #4 (Sell).
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