Roche’s Xofluza (baloxavir marboxil) was approved by the US FDA for influenza
Roche’s announced that the supplemental drug application of Xofluza (baloxavir marboxil) for the treatment of influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications.
The drug acts by inhibiting polymerase acidic endonuclease, an enzyme essential for viral replication, one -dose oral dosage form.
Earlier the drug was approved by the US FDA for the treatment of acute, uncomplicated flu in otherwise healthy people 12 years of age and older.
The approval was based on CAPSTONE-2 study. Xofluza 40mg or 80mg, placebo or 75mg of oseltamivir twice a day for five days was compared. Median time taken for the reduction of symptoms was 73 hours compared 102 hours in oseltamivir group. Diarrhoea (3%), bronchitis (3%), nausea (2%), sinusitis (2%) and headache (1%) are the adverse events reported.