Roche's Novel Anti-Influenza Drug Baloxavir Marboxil (Xofluza) Granted Priority Review in China as a Potential Successor to Tamiflu

Yiou Health, November 2 News: The CDE website announced today that Roche's imported innovative chemical drugBaloxavir Marboxil Tablets(English brand name: Xofluza) marketing application has been included in the proposed priority review.

It is reported that this is a “first-in-class” innovative drug, the first anti- with a novel mechanism of action approved by the U.S. FDA in nearly 20 years.InfluenzaSingle-dose oral antiviral medication. Xofluza is effective with a single dose and can treatOseltamivirDrug-resistant viral strains and avian influenza virus strains (H7N9, H5N1).

Roche is the original developer of oseltamivir. Around 2006, Roche successively licensed East Sunshine Pharmaceutical and Shanghai Zhongxi Pharmaceutical to produce it. Currently, East Sunshine Pharmaceutical dominates the market; in 2019, oseltamivir (brand name:Tamiflu) Sales reached RMB 5.93 billion.

In 2019, the number of reported influenza cases increased by 350% compared to 2018. In the 2019 updated Guidelines for the Diagnosis and Treatment of Influenza, oseltamivir has been listed as a first-line treatment regimen for influenza.

Unlike other anti-influenza drugs that prevent viral spread by targeting neuraminidase, Xofluza inhibits viral replication by suppressing the cap-dependent endonuclease in the influenza virus. It exerts its therapeutic effect during the early stage of influenza self-replication, thereby blocking the flu faster than neuraminidase inhibitors.

Currently, Xofluza has been approved in several countries for the treatment of influenza A and B in children, adolescents, and adults. In the United States, Xofluza received FDA approval for marketing in October 2018, and its indication was expanded the following October to include the treatment of uncomplicated acute influenza in patients aged 12 years and older.

Relevant studies have shown that baloxavir can significantly reduce complications such as pulmonary infections caused by influenza, and it is also well tolerated in pediatric patients. InEpidemicIn the New Normal Era,COVID-19Vaccines and drugs still require time, but Roche’s Xofluza represents a significant advancement over oseltamivir, offering greater potential.

In the first quarter of 2020, Xofluza generated sales of CHF 28 million (approximately RMB 204 million), representing a year-on-year increase of 371%. Roche has also submitted marketing applications to the U.S. Food and Drug Administration (FDA) for baloxavir marboxil oral suspension for the treatment of acute uncomplicated influenza in children aged 1 to 12 years, and for tablets for post-exposure prophylaxis of influenza. These two applications are expected to be approved by late November 2020.

This article is sourced from YiOu, an original piece by author Gao Yushan. For reprinting or collaboration, please click here.Reprint Notice, unauthorized reprints will be subject to legal action.