Genentech Announces FDA Approval of First-in-Class Antiviral Xofluza for Influenza Patients at High Risk of Complications

On October 21, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that biotechnology company Genentech announced its antiviral drug Xofluza had received FDA approval for the treatment of influenza-related complications.

Influenza is an acute respiratory infectious disease caused by the influenza virus, characterized by high contagiousness and rapid spread. It is classified into three types: A, B, and C. Patients typically present with acute high fever, generalized body aches, significant fatigue, and mild respiratory symptoms. Influenza is most prevalent during the autumn and winter seasons and can lead to complications such as sinusitis, otitis media, or pneumonia; in severe cases, it may even result in death.

Genentech, founded in 1976 and headquartered in South San Francisco, USA, is a leading biotechnology company. The company is primarily engaged in the discovery, development, and commercialization of therapeutics for critical diseases. Genentech has partnered with Shionogi & Co., Ltd. to address limitations in antiviral drugs regarding efficacy, routes of administration, and drug resistance, and to advance the commercialization of Xofluza.

Xofluza is the first new antiviral drug approved by the FDA in 20 years for the treatment of influenza-related complications. This prescription medication was approved by the FDA in October 2018, initially for the treatment of acute uncomplicated influenza in patients aged 12 years and older. Currently, Xofluza is available in multiple countries and can be used to treat both influenza A and B.

Unlike other antiviral drugs on the market, Xofluza features a unique mechanism of action. The drug primarily interferes with the viral replication process by inhibiting the cap-dependent endonuclease (CEN) protein, thereby achieving its therapeutic effect. Non-clinical studies involving oseltamivir-resistant strains and avian influenza virus strains (H7N9, H5N1) have demonstrated that this mechanism exhibits potent antiviral activity.

Xofluza can significantly shorten the duration of influenza treatment. Currently, Genentech is conducting Phase III clinical trials to evaluate its therapeutic efficacy in severely ill pediatric patients under one year of age with influenza. Furthermore, Genentech and Shionogi & Co., Ltd. are jointly leading a research project on the transmissibility of influenza.

Clinical trials of Xofluza have shown that the drug may cause severe allergic reactions, such as rash, urticaria, blistering, dizziness, and swelling of the face or mouth. The most common side effects of Xofluza include diarrhea, bronchitis, sinusitis, headache, and nausea, with at least 1% of adult and adolescent patients treated with the drug experiencing these adverse reactions.

Dr. Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech, stated, “Currently, Xofluza is the only FDA-approved medication for the treatment of influenza-related complications. This drug was specifically developed for individuals at high risk of influenza complications, such as those with asthma, heart disease, and diabetes. Patients must promptly communicate with healthcare providers upon experiencing prodromal symptoms and related signs.”

(Compiled by Xu Xiaoxue)