Roche’s Tamiflu successor on target in phase 3 trial

pharmaphorum | July 04, 2019

A trial of Roche’s successor to flu medicine Tamiflu has met its goal in a phase 3 trial, with results showing that the new drug Xofluza is well tolerated in children with the flu. Roche’s Genentech unit said the MINISTONE-2 study also showed Xofluza is comparable with Tamiflu (oseltamivir) in terms of efficacy, the drug that Xofluza is designed to replace. The idea behind Xofluza (baloxavir marboxil) is to replace Tamiflu’s once-daily dosing regimen with a single dose that helps the body to fight the viral infection. Safety and efficacy of Xofluza in children with the flu under the age of one is also being studied in the global phase 3 MINISTONE-1 study. The FDA approved Xofluza last October in adults with uncomplicated flu in people aged 12 years of age and older. This latest study in part of a strategy to expand the drug’s use to include younger children and Roche has already filed a dossier with the FDA asking for an expanded label in people at high risk of complications from the flu. The safety and efficacy of Xofluza in children with the flu under the age of one is also being studied in the global phase 3 MINISTONE-1 study. Although Xofluza was hailed as one of the first novel flu antiviral drugs in almost 20 years at the time of approval, it faces significant competition from generics of Tamiflu. While Xofluza costs as much as $165, generic Tamiflu costs around $50 and it remains to be seen whether doctors and patients think the new drug’s benefits and dosing schedule justify the higher price tag. Xofluza was discovered by Japan’s Shionogi and the two companies are collaborating on development and marketing. Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi.

Spotlight

Successful execution of clinical trials requires the orchestration of multiple moving parts, with everything from protocol design and patient visit schedules, to lab kits and
biological samples needing to seamlessly line up to ensure on-time, on-budget delivery of high-quality data.

Spotlight

Successful execution of clinical trials requires the orchestration of multiple moving parts, with everything from protocol design and patient visit schedules, to lab kits and
biological samples needing to seamlessly line up to ensure on-time, on-budget delivery of high-quality data.

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