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Roche's super flu drug Xofluza is approved by the FDA
Pharmaceutical Network October 26, Swiss pharmaceutical giant Roche (Roche) recently announced that the US Food and Drug Administration (FDA) has approved Xofluza (baloxavir marboxil), a single-dose, oral drug for 12 years old and The above patients are treated with acute, uncomplicated influenza. This approval has made Xofluza the first influenza drug with a new mechanism of action in the past 20 years. In clinical trials, a single treatment with Xofluza can significantly reduce the duration of flu symptoms and significantly reduce viral efficiencies in just one day.
The approval of Xofluza is based on the results of a Phase III clinical study of CAPSTONE-1. The study was a global, multicenter, randomized, double-blind, placebo-controlled phase III study enrolling 1,436 patients in the United States and Japan, aged 12 to 64 years old , with a single dose of Xofluza A comparison was made between placebo and Tamiflu (75 mg twice daily for 5 days). The primary end point was the time to symptom relief (0TTAS). Important secondary endpoints included time to fever, viral shedding stop time, proportion of subjects with positive influenza virus titers, and virus levels in vivo.
The results showed that Xofluza reached the primary and secondary endpoints compared with placebo: (1) significantly reduced the duration of influenza symptoms for more than one day (median time: 53.7 hours vs 80.2 hours, p < 0.001); (2) The fever time was significantly shortened by nearly one day (median time: 24.5 hours vs 42.0 hours, p < 0.001); (3) significantly reduced the duration of virus release from the body (median duration of viral excretion: 24.0 hours vs 96.0 hours, p < 0.001); (4) The nasal and throat virus levels were significantly reduced from 24 hours (first day) to 120 hours (day 5) after treatment.
Compared with Tamiflu, Xofluza showed similar efficacy in terms of duration of symptoms and reduced fever, but significant differences in Xofluza were observed in terms of viral expiration time: (1) There was no significant reduction in duration of symptoms (median) Time: 53.5 hours vs 53.8 hours, p=0.7560); (2) There was no significant decrease in fever time (median time: 24.4 hours vs 24.0 hours, p=0.9225); (3) The duration of virus release from the body was significantly reduced ( Virus excretion: 24.0 hours vs 72.0 hours, p < 0.001); (4) Nasal and throat virus levels were significantly reduced from 24 hours (first day) to 120 hours (day 5) after treatment.
In this study, Xofluza was well tolerated and the overall incidence of adverse events (20.7%) was slightly lower than in the placebo group (24.6%) and the Tamiflu group (24.8%). The most common adverse events in the Xofluza treatment group were diarrhea (3%), bronchitis (2.6%), nausea (1.3%), and sinusitis (1.1%), all of which were lower than those in the placebo group.
Xofluza: Super flu medicine, once a day, kills the virus within 24 hours
The flu is one of the most common but serious infectious diseases and poses a major threat to public health . Worldwide, resulting in an annual popular 3 million to 5 million cases of severe illness, millions of people in hospital, up to 65 million deaths.
Xofluza is a first-in-class, single-dose experimental oral drug with a novel anti-influenza mechanism that is different from other antiviral drugs in the market. It is an endonuclease inhibitor. In inhibiting the CAP cap structure-dependent endonuclease in influenza viruses, this enzyme is essential for the replication of influenza viruses. Xofluza is designed to fight against influenza A and B viruses, including the oseltamivir (oseltamivir) and avian influenza strains (H7N9, H5N1). Duffy is developed by Gilead and Roche is responsible for the global commercialization. It is a widely used anti-influenza oral medication. It usually takes several consecutive days and is taken twice a day. It usually takes 72 hours to take effect.
Xofluza can kill the flu virus within 24 hours, but some symptoms may last longer. Xofluza only needs to be taken orally once, and it is also suitable for adults and children. Therefore, it is very convenient to use and the patient's medication compliance will be greatly improved.
In July of this year, Roche announced that the global phase III clinical trial of CAPSTONE-2, which evaluated the efficacy and safety of Xofluza in high-risk populations with flu complications of 12 years and older, reached its primary endpoint and showed superior efficacy. Currently, Xofluza is being evaluated in a Phase III clinical development program, including child groups, post-exposure prophylaxis, and severe hospitalization for influenza, and is being evaluated for potential to reduce transmission in other healthy populations.
Baloxavir marboxil was discovered by Shionogi, a Japanese pharmaceutical company, and was jointly developed by Roche and Yunoi. According to the agreement, Roche enjoys the global rights of the drug in addition to Japan and Taiwan. In February of this year, baloxavir marboxil was approved by the Ministry of Health, Labor and Welfare (MHLW) and sold under the brand name Xofluza in Japan for the treatment of influenza A and B in adult and pediatric patients.
Article reference source: Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza