Roche Snags FDA Approval for First New Flu Drug in 20 Years
For the first time in nearly 20 years, the U.S. Food and Drug Administration (FDA) has approved a new treatment for the flu. The regulatory agency green lit Roche’s Xofluza, a single-dose oral medication, just ahead of the 2018-19 flu season.
Xofluza (baloxavir marboxil) was approved for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. The new medication has a novel mechanism of action that, Roche said, inhibits polymerase acidic endonuclease, an enzyme that is essential for the flu virus to replicate.
Sandra Horning, Roche’s chief medical officer and head of global product development, touted the approval of the first new flu medication in two decades and added that the company was excited to offer a “convenient treatment option” that reduces flu symptoms by more than a single day with a single dose.
“If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms,” Horning said in a statement.
Xofluza snagged regulatory approval based on the CAPSTONE-1 study Xofluza demonstrated a clinically significant benefit over placebo in otherwise healthy people with influenza. Baloxavir marboxil reduced the time that the virus continued to be released, called viral shedding, and also reduced viral levels in the body. In non-clinical studies, Xofluza demonstrated efficacy against a number of flu viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1), Roche said. The FDA approved the drug under Priority Review.
The flu represents a serious health threat each year. Globally, there are about 650,000 deaths from the flu worldwide and millions of people are hospitalized due to the illness. According to the U.S. Centers for Disease Control and Prevention, those people who are considered at high risk of serious flu complications include people over the age of 65, as well as people who have pre-existing conditions such as asthma, diabetes, heart disease or chronic lung disease. Xofluza is expected to be available within a few weeks.
FDA Commissioner Scott Gottlieb said Xofluza provides an important treatment option for flu patients. However, even with the new flu drug approved, he said it was important for people to get a flu shot annually.
“While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination. Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks,” Gottlieb said in a statement.
Earlier this month, Roche’s subsidiary Genentech released data from the Phase III CAPSTONE-2 trial that showed Xofluza significantly reduced the time to improvement of influenza symptoms versus placebo in patients who are at high risk of serious complications from the flu. The study showed that people who took Xofluza saw a reduction in time for symptom improvement in influenza type A/H3N2 and type B by 75.4 hours and 74.6 hours, respectively. In the CAPSTONE-2 study, Xofluza fared slightly better than Genentech’s other flu drug, Tamiflu.