Type of information: Granting of a Market Authorisation in the US
Product name: Xofluza®
Compound: baloxavir marboxil
Therapeutic area: Infectious diseases
- antiviral/enzyme inhibitor. Xofluza® is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication. Xofluza has demonstrated efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.
- Xofluza® was discovered by Shionogi and is being further developed and commercialised globally in collaboration with the Roche Group. Under the terms of this agreement, Roche holds worldwide rights to Xofluza® excluding Japan and Taiwan, which will be retained exclusively by Shionogi.
Company: Roche (Switzerland) Shionogi (Japan)
- • On October 24, 2018, the FDA approved Xofluza® (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours. Xofluza® is the first new flu medicine with a novel proposed mechanism of action approved in nearly 20 years. The drug inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.
- The safety and efficacy of Xofluza® , an antiviral drug taken as a single oral dose, was demonstrated in two randomized controlled clinical trials of 1,832 patients where participants were assigned to receive either Xofluza® , a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms. CAPSTONE-1 study of a single-dose of Xofluza® compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu, as well as results from a placebo-controlled phase II 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. In clinical trials, Xofluza® was safe and well-tolerated with a side effect profile similar to placebo. The CAPSTONE-1 and phase II study results were recently published in the 6 September 2018 issue of the New England Journal of Medicine.
- In both trials, patients treated with Xofluza® had a shorter time to alleviation of symptoms compared with patients who took the placebo. In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received Xofluza® and those who received the other flu treatment.
- Xofluza® was granted Priority Review under which the FDA’s goal is to take action on an application within an expedited time frame where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2018-10-24
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: