Novel single dose treatment for Influenza - FDA approves Xofluza (Baloxavir marboxil)

 
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02 Nov, 2018 - After nearly two decades, a new antiviral drug - Baloxavir marboxil (Xofluza) is now approved by FDA for treatment of influenza. It is a single dose therapy approved for uncomplicated acute influenza in patients 12 years of age and above within 48 hours of onset of symptoms. It is also useful in treatment of patients with oseltamivir resistant influenza.
Baloxavir marboxil is a selective inhibitor of influenza cap- dependent endonuclease. It prevents replication by inhibiting the process known as 'cap snatching' which is performed by cap-dependent endonuclease of PA subunit.
It is administered orally in the dose of 40 mg for patients weighing <80 kg or 80 mg for above 80kgs weight.
This molecule was studied in a phase 3 trial, CAPSTONE -1 and was compared with placebo and oseltamivir (75 mg twice daily for five days), in otherwise healthy people with the flu. It significantly reduced the duration of flu symptoms compared to placebo, and demonstrated similar efficacy compared to oseltamivir
In clinical trials, it was safe and well-tolerated with a side effect profile similar to placebo. Adverse effects seen in about 1% of patients were diarrhea, bronchitis, nasopharyngitis, nausea, sinusitis, headache, vomiting and dizziness.
Baloxavir marboxil is developed by Shinogi Co., a Japanese pharmaceutical company and Roche AG.
It appears to be promising as a single dose for uncomplicated acute influenza but further research is warranted for its use in complicated influenza.
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