Roche has begun selling Xofluza in Spain. The oral antiviral blocks flu replication early and is taken in one dose within 48 hours.
In the week of 21-27 September 2026, Spain recorded 478.2 cases of acute respiratory infection per 100,000 inhabitants. The figure was 28.2% higher than the week before, according to the latest SiVIRA report from the Instituto de Salud Carlos III.
Roche is now bringing Xofluza to the Spanish market. The prescription medicine contains baloxavir marboxil and is taken orally in a single dose. Roche says its arrival represents Europe's first approval of an innovative influenza antiviral in 20 years.
The drug works early in the infection cycle. Baloxavir marboxil blocks cap-dependent endonuclease, an enzyme the influenza virus needs to make new copies. That mechanism differs from oseltamivir and other neuraminidase inhibitors.
Baloxavir marboxil works by inhibiting the influenza virus’s cap-dependent endonuclease, blocking a key step in viral replication.
Timing is strict. The dose should be taken as soon as possible within 48 hours in two situations. One is the start of flu symptoms, when treatment aims to limit the illness. The other is close contact with someone known or suspected to have the infection.
This is an early-use medicine. It is not designed for an infection that has already been established for several days.
Spain has already crossed the epidemic threshold for acute respiratory infections. The latest SiVIRA report recorded 478.2 cases per 100,000 inhabitants during the week of 21-27 September 2026. The rate rose 28.2% from the previous week.
That does not mean influenza is leading the current rise. In positive primary-care samples from the same week, COVID-19 accounted for 27.2% and influenza for 4.1%, according to SiVIRA and the Instituto de Salud Carlos III.
The latest Spanish surveillance data describe an early, low-intensity respiratory upturn rather than a peak flu wave. Among positive primary-care samples in the week of 21–27 September 2026, COVID-19 accounted for 27.2%, while influenza accounted for 4.1%, so COVID-19 was the larger contributor to the current burden.
The previous flu season shows why early treatment matters. During 2024-2025, the epidemic ran from the end of December to the beginning of March and reached its highest point at the end of January. Primary care then recorded an estimated 403 flu cases per 100,000 inhabitants. Influenza was present in 50.2% of analysed samples.
Roche also cites the hospital burden from that season in Spain. Its figures include around 33,000 hospitalisations, 1,800 intensive care admissions and 1,800 hospital deaths linked to influenza.
People aged 60 and over made up 77% of hospitalisations and 94% of hospital deaths. Roche presents these numbers as an indication of the previous season's burden. They should be read alongside the underlying health-authority reports.
José María Eiros, professor of Microbiology at the Universidad de Valladolid and head of the Microbiology Service at Hospital Universitario Río Hortega de Valladolid, says early action matters in flu care. He argues that medicines acting directly on viral multiplication can expand the available treatment options because they use mechanisms different from existing drugs.
Older and vulnerable patients face the greatest risks. The wider respiratory situation in Spain was also reported earlier in connection with public health conditions and disruption.
Baloxavir marboxil is a targeted addition, not a replacement for medical assessment. It requires a prescription. Patients must reach the treatment or preventive-contact window within 48 hours.
Xofluza is not new worldwide. Its expansion in Europe has taken longer. European regulatory materials describe it as a treatment and preventive option for influenza, while Roche and medical coverage present its arrival as a notable addition after a long period without a fundamentally new influenza drug class.
One dose matters. The early mechanism matters too.
Together, they give doctors another defined option while flu continues to place pressure on hospitals. The drug's value will depend on early use and appropriate prescribing, especially for older adults and other vulnerable patients.
Current surveillance calls for care with the wider picture. Spain is in an early, low-intensity rise in respiratory infections, but the latest figures do not show influenza as the dominant cause. COVID-19 accounted for a much larger share of positive primary-care samples than influenza during the week of 21-27 September 2026.
