FDA approves new mechanism for listing new anti-influenza drugs


Today, the US FDA announced the approval of the new anti-influenza drug Xofluza (baloxavir marboxil), jointly developed by Shionogi and Roche, for the treatment influenza patients over 12 years of age. This is the first anti-influenza drug with an innovative mechanism of action approved by the FDA in the past 20 years.


The flu is an infectious respiratory disease caused by an influenza virus infection. It is a serious threat to public health. Worldwide, there are approximately 3 to 5 million severe influenza patients each year, more than 1 million patients require hospitalization for care, and approximately 650,000 people die. The use of antiviral drugs can reduce the symptoms and duration of the disease within 48 hours.


Developed by Shionogi Pharmaceutical Co., Ltd. and Roche, Xofluza is a "first-in-class" oral antiviral drug that can be taken only once. It is capable of treating strains that are resistant to oseltamivir and avian influenza strains (H7N9, H5N1). The mechanism of action of Xofluza is different from that of existing antiviral therapies. It inhibits viral replication by inhibiting cap-dependent endonuclease in influenza viruses. The mechanism of action of anti-influenza drugs has been through the targeting of neuraminidase. Compared to these drugs, Xofluza targets the earlier stages of the viral replication cycle. Xofluza's new drug application in the United States received the FDA's priority review.


The approval is based on Xofluza's results in Phase 3 clinical trials involving a total of 1832 influenza patients. In both trials, the patient received treatment with Xofluza, placebo or another anti-influenza drug. The results of the trial showed that the time to onset of symptoms and the duration of symptoms were significantly reduced in patients receiving Xofluza after taking the drug compared with placebo. And the time to release the virus is significantly shorter, which will help control the spread of the flu.


“This is the first new anti-influenza therapy with an innovative mechanism approved by the FDA in the last 20 years. Thousands of patients are infected with the flu every year, many of whom are very symptomatic. It is very important to have safe and effective treatment options. The new drug offers an important medical option,” said Dr. Scott Gottlieb, FDA Director.


Dr. Debra Birnkrant, Director of the Antiviral Products Division of the FDA's Center for Drug Evaluation and Research, added: "It's vital to have more treatment options that use different mechanisms to attack the virus, because the flu virus can resistance to viral drugs."