Reports emerged that Genentech, a Roche company reached primary endpoint of its Phase III clinical trial called MINISTONE-2, demonstrating that Xofluza (balaxavir marboxil) was comparable to Tamiflu (oseltamivir). Tamiflu has been prevalent in the market from last two decades. Xofluza is broadly approved in the markets of Japan for people older than 12 years. The objective of the company behind this trial is to market Xofluza as an alternative to Tamiflu.
Clinical trial was conducted on children between the ages of one to twelve, who were suffering from Flu infection. Confirmatory tests; rapid influenza test were done to include the subject as per inclusion criteria. Outcome of the test showed symptoms similar to influenza which includes 38°C or higher temperature along with one or more respiratory symptoms.
Study was divided into two cohorts. Cohort one included subjects (children) from one year to five years while Cohort two included subjects from five years to twelve years. Subjects had randomly received one dose (adjusted as per the BMI) of Xofluza or Tamiflu twice a day over five days.
Genentech has announced that the trial has met the primary endpoints, which shows that the Xofluza is well tolerated among children in comparison to Tamiflu administered for the reduction in symptoms and duration of Flu.
Clinical Research Newsletter
Mr Vinod Arora, Principal Advisor, IGMPI
Placement testimonials: Our alumni are working with Fortune 500 and global Pharmaceutical, Food and healthcare giants like