Dive Brief:
- The Food and Drug Administration on Wednesday approved the first new treatment with a novel way of treating the influenza virus in nearly 20 years, granting Japanese drugmaker Shionogi an OK for Xofluza.
- In Phase 2 and 3 clinical trials, a single oral dose of Xofluza taken within 48 hours of symptom onset significantly reduced the duration of flu symptoms compared with placebo in otherwise healthy and in high-risk patients. Xofluza was similarly effective to Roche's Tamiflu, which is taken over five days.
- While Xofluza was developed by Shionogi, the Japanese company licensed the drug to Roche for commercialization outside of Japan and Taiwan. Phase 3 studies are planned in children, post-exposure prophylaxis, and severely ill hospitalized people with influenza, as well as to assess its role in reducing transmission in otherwise healthy people.
Dive Insight:
Roche hopes that Xofluza will plug a gap in its infectious disease revenue, as Tamiflu (oseltamivir) has faced generic competition since 2016. Tamiflu posted global sales exceeding $3 billion in 2009, but those sums have steadily fallen since then. In 2017, sales dropped by one-third compared with the previous year, from about $794 million to roughly $535 million.
As the flu season approaches in the Northern Hemisphere, news of a drug that can shorten the duration of influenza symptoms, even by a matter of a day or two, may be warmly welcomed. While the efficacy of Roche's Xofluza (baloxavir marboxil) is similar to that of Roche's Tamiflu, it will play a role in the armory of drugs against what can be a deadly infection.
"Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs," said Debra Birnkrant, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research in a statement.
One benefit of Xofluza over Tamiflu is its single dose rather than a five-day regimen, and it cuts viral shedding, which could potentially reduce the transmission of the bug.
Regulators cautioned, however, that antiviral drugs to treat already developed flu symptoms aren't a substitute for vaccination.
The 2017/2018 flu season in the U.S., according to the Centers for Disease Control and Prevention, was a high severity season with high levels of influenza-related clinic and emergency department visits and hospitalization.
While no vaccine figures are yet available for the 2017/2018 season, vaccination during the 2016/2017 season averted around 5.29 million deaths 2.64 million medical visits, and 84,700 influenza-associated hospitalizations..