The FDA has approved Roche’s new flu treatment Xofluza (baloxavir marboxil), the first new antiviral drug in nearly 20 years.
The treatment has been approved for acute, uncomplicated influenza in people 12 years of age and older, and has been shown to be effective against a wide range of flu viruses, including those resistant to Roche’s now off-patent and former blockbuster flu treatment, Tamiflu.
Xofluza can reduces flu symptoms by more than a day, but only if they visit their doctor within 48 hours of flu symptoms emerging.
The drug’s pivotal trials failed to show that it could outperform Tamiflu in terms of cutting the duration of the flu, however, which will undoubtedly restrict its uptake. Xofluza is given as a convenient single (one time) dose compared to Tamiflu’s twice daily dosing.
The FDA approved the treatment well ahead of its 24 December deadline, mindful that it could help as the flu season gets under way. The US regulator stressed, nevertheless, that flu vaccination was the best way of fighting what is one of the most common, but potentially deadly infectious diseases.
Globally, annual epidemics result in 3-5 million cases of severe disease, millions of hospitalisations and up to 650,000 deaths worldwide.
Xofluza was approved based on results from the phase 3 CAPSTONE-1 study of a single-dose of Xofluza compared with placebo or Tamiflu (oseltamivir) 75 mg, twice daily for five days, in otherwise healthy people with the flu, as well as results from a placebo-controlled phase 2 study in otherwise healthy people with the flu. Xofluza significantly reduced the duration of flu symptoms compared to placebo, and demonstrated similar efficacy compared to oseltamivir.
Discovered and developed by Shionogi, the drug is already approved in Japan, with Roche holding the marketing rights outside Japan and Taiwan.
The drug is also to be studied in a phase 3 programme including paediatric patients and severely ill hospitalised patients with influenza.
Analysts say the new treatment will have to generate more evidence of significant benefits in these high risk groups in order for healthcare systems to switch away from generic oseltamivir.
Roche is in need of a new set of innovative products, as its older generation of blockbusters, Avastin, Herceptin and MabThera/Rituxan come under competition from biosimilars. This week saw the company unveil strong Q3 results, which managed to overcome the biosimilar onslaught, thanks to growth in new products such as multiple sclerosis drug Ocrevus.