Roche's Xofluza (Baloxavir Marboxil) Receives FDA Approval for Post-Exposure Prophylaxis of Influenza in Individuals Aged 12 and Older

On November 24, Roche announced that the U.S. FDA had approved its supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil) for post-exposure prophylaxis of influenza in individuals aged 12 years and older following contact with an influenza patient. The press release noted that Xofluza is the first single-dose influenza medication approved for post-exposure prophylaxis.

The results of the Phase 3 clinical study BLOCKSTONE, which evaluated single-dose Xofluza for post-exposure prophylaxis, were recently published in The New England Journal of Medicine. The Phase 3 BLOCKSTONE study assessed the efficacy of Xofluza versus placebo as preventive treatment for household contacts (adults and children) living with influenza patients. Xofluza demonstrated statistically significant efficacy in preventing influenza among household contacts exposed to influenza patients after a single oral dose; the incidence of influenza was 1% in subjects treated with Xofluza compared with 13% in the placebo group among household contacts aged 12 years and older. Xofluza was well tolerated in this study, and no new safety signals were identified.

Xofluza is a first-in-class, single-dose oral medication co-developed by Roche and Shionogi & Co., Ltd., which demonstrates efficacy after a single administration. The drug is effective against oseltamivir-resistant viral strains as well as avian influenza virus strains (H7N9, H5N1). Unlike other anti-influenza drugs that prevent viral spread by targeting neuraminidase, Xofluza inhibits viral replication by blocking the cap-dependent endonuclease of the influenza virus.

The press release noted that Xofluza is the first novel antiviral drug approved by the FDA in 20 years. Xofluza was previously approved in the United States for the treatment of influenza A and B in patients aged 12 years and older with acute, uncomplicated influenza who are otherwise healthy or at high risk of developing serious influenza-related complications, and whose symptoms have been present for no more than 48 hours. Currently, Roche is confirming with the FDA the potential indication of Xofluza for the treatment and prophylaxis of acute uncomplicated influenza in children aged 1 to 12 years. Xofluza is also being further evaluated in Phase 3 clinical studies for use in children under 1 year of age (NCT03653364) and for its potential to reduce the transmission of influenza from infected individuals to healthy populations (NCT03969212).

Notably, earlier this month, the drug’s marketing authorization application submitted in China was proposed for inclusion in the priority review program, with the proposed indication being for the treatment of influenza in patients aged 12 years and older, including those at high risk for influenza-related complications. Six days ago, the drug was officially included in the third batch of the List of Overseas New Drugs Urgently Needed for Clinical Use, as published by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration.

Source: Jike Pharmaceutical News

▽Follow [WuXi AppTecDe】WeChat Official Account