FDA Confirms Paragraph IV Patent Litigation for Baloxavir Marboxil Tablets
Basel, 12 January 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Xofluza® (baloxavir marboxil) in children aged one year and above for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza. Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus. The Commission’s Decision is based on the results of the phase III miniSTONE-2 and BLOCKSTONE studies.1,2 This approval marks the first single-dose, oral influenza medicine approved in Europe for children, and now means that Xofluza can be used to treat and prevent uncomplicated influenza in children aged one year and above, and in adolescents and adults.3
ZURICH (Reuters) - Roche 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, the drugmaker said on Friday.
Genentech Announces FDA Approval of Xofluza
Molnupiravir’s 50% reduction in hospitalization and death risk came from the MOVe-OUT study in high-risk, unvaccinated adults. That profile description only fits about 15% of the U.S. population, Gal noted. Merck may argue that vaccinated, high-risk patients should also be eligible for molnupiravir, but, given the impressive protection already offered by the vaccine, the drug will have a hard time making that case, Gal said.
ZURICH (Reuters) - Swiss drugmaker Roche said the European Commission approved its Xofluza to treat influenza in patients aged 12 years and above, the first new influenza antiviral for patients in almost 20 years, Roche said on Monday.
Roche’s Xofluza has been approved in the U.S. to treat the flu for two years now, but sales have been languishing as it battles cheap generics of its predecessor Tamiflu. Now, a new FDA green light could add some extra oomph to the drug’s market performance.
Today, the U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
EMA’s human medicines committee (CHMP) recommended five medicines for approval at its November 2020 meeting.
In the United States, antiviral treatment of influenza is recommended as soon as possible in hospitalized patients and in outpatients who are at increased risk for influenza complications or have progressive disease, and it can be considered in non–high-risk patients presenting within 2 days after the onset of illness (early treatment).1,2 The neuraminidase inhibitors oseltamivir, zanamivir, and peramivir have been approved by the Food and Drug Administration (FDA) for the early treatment of uncomplicated influenza. Oseltamivir is recommended for the treatment of influenza in hospitalized patients.1 Neuraminidase inhibitors block the influenza viral surface protein neuraminidase to inhibit release of progeny . . .