Roche on Friday announced that it has received approval from the U.S. Food and Drugs Administration for its Xofluza drug to treat influenza in children aged five years and older.
According to Reuters’ report, the medicine has been approved to treat acute uncomplicated influenza in otherwise healthy children who have shown symptoms for no more than 48 hours.
The FDA also approved Xofluza to prevent influenza in children aged five years and above following contact with an infected person.
The company claims that the drug becomes the first single-dose oral influenza medicine approved in the United States for children in this age group. Moreover, Xofluza is already FDA-approved to treat influenza in people aged 12 and above.
Xofluza is a single-dose oral medicine with a novel proposed mechanism of action that has demonstrated efficacy against a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies, the company claims.
Meanwhile, Xofluza is also approved for acute uncomplicated influenza in 27 other countries including Japan, Switzerland, Canada, Australia and South Korea, and is currently under review by the EMA.
(With inputs from Reuters)