On October 20 2018, Xofluza (baloxavir marboxil) became the first medicine to achieve FDA approval for the treatment of the influenza virus, better known as ‘the flu’, in 20 years.

The severity of illness from the flu can vary greatly between individuals from mild to severe, and the WHO estimates that the global incidence ranges from 3 to 5 million cases of severe illness and 290,000 to 650,000 respiratory deaths a year.

Previous first-choice therapies for influenza include anti-viral drugs, neuraminidase inhibitors such as Relenza (zanamivir) and Tamiflu (oseltamivir) and finally viral M2 protein inhibitors, which include amantadine and rimantadine.

Developing Xofluza

Roche has assisted the development of Xofluza since it completed a licensing agreement with Shionogi & Co. in February 2016. Two and a half years later they have managed to successfully introduce the drug to the US market.

Approval followed two randomised controlled clinical trials of 1,832 patients where participants were assigned to receive either Xofluza, a placebo, or another antiviral flu treatment Tamiflu.

Xofluza demonstrated a stronger efficacy than the placebo and a shorter recovery time than patients who received a standard dose of Tamiflu. It is the first of its kind and operates by inhibiting the enzyme polymerase acidic endonuclease, which is needed for the flu virus to replicate.

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Financial implications

Xofluza is not expected to reach shelves in the US until 2020; however, it is expected to generate strong financial growth for Roche in the near future, producing an annual revenue of $204 million by 2024.

Shionogi & Co. has already experienced commercial success from Xofluza, having marketed the drug in Japan already.

Although Xofluza will diversify the products available to flu patients, seasonal flu vaccinations will remain the primary therapy choice for the prevention of the infectious disease.

“Yearly early vaccination is the primary means of preventing and controlling flu outbreaks,” stated FDA Commissioner Dr Scott Gottlieb.