FDA accepts Roche ’s New Drug Application for Xofluza (baloxavir marboxil) for the treatment of influenza in children

Basel, 27 March  2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluza® (baloxavir marboxil). The FDA accepted a NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more convenient option for children and those who have difficulty swallowing. In addition, the application seeks approval of Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to l ess than 12 years of age who have been symptomatic for no more than 48 hours. The FDA also accepted a sNDA for post-exposure prophylaxis of influenza in people one year of age and older for both the oral suspension and currently-available tablet formulation. The FDA is expected to make a decision on approval by 23 November, 2020.“As this has been one of the hardest-hitting influenza seasons for children in the past decade, there is a critical need for additional treatment options that attack influenza in different ways. Today’s milestone brings us closer to providing one-dose Xofluza to children with influenza,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We also look forward to working with the FDA to incorporate Xofluza as a preventive treatment following exposure to influenza.” The proposed additi...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news