FDA accepts oral flu drug baloxavir marboxil for priority review

The US Food and Drug Administration has accepted a New Drug Application (NDA) and granted priority review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in patients 12 years and older, says Swiss pharma giant Roche (ROG: SIX).

The FDA is expected to make a decision on approval by December 24, 2018.

"The severity of the recent flu season underscores the need for new options beyond currently available treatments, and if approved, baloxavir marboxil would be the first flu medicine with a novel proposed mechanism of action in nearly 20 years," said Sandra Horning, chief medical officer and head of global product development. "Baloxavir marboxil has been shown in clinical trials to decrease the duration of symptoms with one dose, and demonstrated a significant reduction in viral shedding in just one day. We look forward to working with the FDA during the review process," Dr Horning added.

Already marketed in Japan