Roche Submits NDA for Xofluza (Baloxavir Marboxil), the First Novel Mechanism Anti-Influenza Drug in Two Decades, in China

Text | Baihuawen

On June 10, Roche’s marketing application for baloxavir marboxil tablets (brand name: Xofluza), an influenza drug, was accepted by the Center for Drug Evaluation (CDE) in China.

Xofluza is a first-in-class oral antiviral drug that demonstrates efficacy with a single dose and is effective against oseltamivir-resistant influenza strains as well as avian influenza strains. Unlike anti-influenza medications that target neuraminidase, Xofluza inhibits viral replication by blocking the cap-dependent endonuclease of the influenza virus. By exerting its therapeutic effect during the early stage of influenza self-replication, it blocks the progression of influenza more rapidly than neuraminidase inhibitors.

Xofluza, co-developed by Shionogi and Roche, was first approved in Japan in February 2018. In October of the same year, it was approved in the United States for the treatment of acute uncomplicated influenza in patients aged 12 years and older. As the first globally approved anti-influenza drug with a novel mechanism of action in nearly two decades, this indication has currently been approved in Hong Kong and Taiwan, China.

In October 2019, the FDA approved a new indication for Xofluza for the treatment of influenza in individuals aged 12 years and older who are at high risk of developing complications. In the first quarter of 2020, Xofluza generated sales of CHF 28 million, representing a year-on-year increase of 371%. Roche has also submitted marketing applications to the 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 November 23, 2020.

Influenza causes approximately 3 to 5 million severe cases globally each year, resulting in millions of hospitalizations and 650,000 deaths, posing a significant threat to public health. The primary influenza treatment available in the Chinese market is HEC’s Kewei (oseltamivir), which achieved sales of RMB 5.94 billion in 2019. Currently, multiple generic versions of oseltamivir have been submitted for marketing approval in China; their eventual approval will exert considerable competitive pressure on HEC. Furthermore, the anticipated approval and launch of Roche’s novel anti-influenza drug, Xofluza, is expected to intensify competition in the domestic influenza market.