Genentech, a Roche company, announced that its Phase III MINISTONE-2 clinical trial hit its primary endpoint, showing that its Xofluza (baloxavir marboxil) was comparable to its own Tamiflu (oseltamivir). It was also well-tolerated in children with the flu.
Genentech, a Roche company, announced that its Phase III MINISTONE-2 clinical trial hit its primary endpoint, showing that its Xofluza (baloxavir marboxil) was comparable to its own Tamiflu (oseltamivir). It was also well-tolerated in children with the flu.
The trial compared Xofluza to Tamiflu in children between the ages of one and 12 years with the flu. Tamiflu has been on the market for 20 years. Xofluza is approved broadly in Japan and for people older than 12 years in the U.S. The company is hoping to market Xofluza as an alternative to Tamiflu that is more convenient. Tamiflu has to be taken twice a day for five days, and is off-patent, making it vulnerable to generic copies.
“Children need new medicines for the flu because they are at higher risk of developing the flu and more likely to have complications such as breathing problems and pneumonia,” stated Sandra Horning, Roche’s chief medical officer and head of Global Product Development. “These flu complications, which in some cases can be fatal, lead to approximately one million children under five being admitted to the hospital globally every year.”
Horning added, “As a one-dose oral suspension medication, Xofluza could potentially provide a convenient treatment option for children with the flu, and we look forward to sharing these data with health authorities around the world.”
Tamiflu is typically covered by insurance. A course of the drug can run over $100, although many retail chains make it available for less than $70. And generic versions may be less expensive. Xofluza’s list price is about $150.
Xofluza is currently approved in several countries including Japan and the U.S. for treatment of influenza types A and B. The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Xofluza as a one-dose oral therapy for patients at high risk of flu complications. The FDA has a target action date of November 4, 2019, for the sNDA.
MINISTONE-2 compared the two drugs in otherwise healthy children between the ages of one and 12 whose flu infection was confirmed by a rapid influenza test and showed influenza-like symptoms, including a temperature of 38°C or higher and one or more respiratory symptoms.
There were two cohorts: patients five years of age to less than 12 and patients one year of age to less than five years. They were randomly chosen to receive one dose of Xofluza or Tamiflu twice a day over five days, with dosing adjusted for body weight. The primary endpoint was proportion of patients with adverse events or severe adverse events up to day 29 of the trial. Secondary endpoints included pharmacokinetics, time to alleviation of flu symptoms, and duration of symptoms, including fever.
Genentech hasn’t released much actual data on the trial other than to say that it met its primary endpoint, showing that Xofluza was well-tolerated in the children and that it was comparable to Tamiflu at decreasing the symptoms and duration of the flu. Full results with be presented at an upcoming medical conference.
