Roche is bringing Xofluza to the Spanish market. The prescription medicine contains baloxavir marboxil, is taken orally in a single dose and blocks influenza replication early. Roche says this is Europe's first approval of an new influenza antiviral in 20 years.
During the week of 21-27 September 2026, Spain recorded 478.2 cases of acute respiratory infection per 100,000 inhabitants, 28.2% more than the week before, information from the latest SiVIRA report from the Instituto de Salud Carlos III.
Baloxavir marboxil blocks cap-dependent endonuclease, an enzyme the influenza virus needs to make new copies. Its mechanism differs from that of oseltamivir and other neuraminidase inhibitors.
Timing is strict: the dose should be taken as soon as possible, within 48 hours, in either of two situations. The first is the onset of flu symptoms, when treatment aims to limit the illness. The second is close contact with someone known or suspected to have the infection.
This medicine is intended for early use, not for an infection that has already been established for several days.
Spain has 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, 28.2% above the previous week's rate.
That does not mean influenza is driving the current rise. Among positive primary-care samples from the same week, COVID-19 accounted for 27.2% and influenza for 4.1%, information from SiVIRA and the Instituto de Salud Carlos III.
The previous flu season shows why early treatment matters. In 2024-2025, the epidemic ran from late December to early March and peaked in late January. Primary care recorded an estimated 403 flu cases per 100,000 inhabitants. Influenza was detected in 50.2% of analysed samples.
Roche also cites the hospital burden in Spain that season: around 33,000 hospitalisations. The company reports 1,800 intensive care admissions, as well as 1,800 hospital deaths linked to influenza.
People aged 60 and over accounted for 77% of hospitalisations and 94% of hospital deaths. Roche presents these figures as an indication of the previous season's burden; they should be considered 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 broaden treatment options because they work through mechanisms different from those of 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 adds a targeted option alongside medical assessment. It requires a prescription, and patients must reach the treatment or preventive-contact window within 48 hours.
Xofluza is not new worldwide; its rollout in Europe has taken longer. European regulatory materials describe it as a treatment and preventive option for influenza. Roche and medical coverage present its arrival as a impressive addition after a long period without a fundamentally new class of influenza drugs.
A single dose and an early-acting mechanism give doctors another defined option as flu continues to pressure hospitals. The drug's value will depend on early use and appropriate prescribing, particularly for older adults and other vulnerable patients.
Current surveillance calls for caution in interpreting the wider picture. Spain is seeing an early, low-intensity rise in respiratory infections, but the latest figures do not identify influenza as the dominant cause. During the week of 21-27 September 2026, COVID-19 accounted for a much larger share of positive primary-care samples than influenza.
