Roche’s Xofluza proves non-inferior to Tamiflu in children with flu
pharmafile | July 3, 2019 | News story | Research and Development | Roche, Tamiflu, flu, pharma
Roche has unveiled new Phase 3 data indicating that Xofluza (baloxavir marboxil) was well-tolerated and of comparable efficacy to its other therapy Tamiflu (oseltamivir) in the reduction of the duration of the symptoms of flu, including fever, in otherwise healthy child patients between the ages of one and 12.
Flu is very common in this patient population, with one in three children developing the disease every year, with symptoms often persisting longer than in adult patients. Thus, reduction of symptom prevalence in these patients could have wider benefit for the community by preventing the spread of the disease.
The findings presented showed that Xofluza met its primary endpoint of reduction in the proportion of patients with adverse events or severe adverse events after 28 days of treatment. The drug is already approved in the treatment of flu in adults – the first of its kind approved by the FDA in two decades – and, according to Roche, “the only flu treatment shown to be efficacious in both otherwise healthy people with flu and people at high risk of complications from flu, as well as a preventive measure against developing flu following exposure to an infected household member”.
“Children need new medicines for flu because they are at higher risk of developing flu and more likely to have complications such as breathing problems and pneumonia,” explained Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “These flu complications, which in some cases can be fatal, lead to approximately one million children under five being admitted to hospital globally every year. As a one-dose oral suspension medicine, Xofluza could potentially provide a convenient treatment option for children with flu, and we look forward to sharing these data with health authorities around the world.”
The FDA said it aims to reach a decision on whether to extend the drug’s indication to cover paediatric flu patients by 4 November 2019.
Matt Fellows
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