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Medical [Medical] More on Xofluza
2019.03.06 09:05
FDA to Review Xofluza sNDA for Flu Treatment in High Risk Patients
If approved, Xofluza would be the first antiviral approved for flu treatment specifically in high-risk patients
The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil; Genentech) for the treatment of influenza in patients at high risk of complications.
High risk individuals may include patients ≥65 years of age, or those with comorbid conditions (i.e., asthma, chronic lung disease, morbid obesity or heart disease). The sNDA is based on data from the phase 3 CAPSTONE-2 trial which included 2184 patients (≥12 years of age) who were at high risk for complications from the flu. Patients were randomized to receive a single dose of baloxavir marboxil at 40mg or 80mg, placebo, or oseltamivir 75mg twice daily for 5 days.
Results showed that baloxavir marboxil significantly reduced the time to improvement of influenza symptoms versus placebo (median time 73.2 hours vs 102.3 hours; P<.0001) and reduced the time to improvement of symptoms vs placebo and oseltamivir in influenza type B (median time of 74.6 hours vs 100.6 hours and 101.6 hours, respectively (P=.0138, P=.0251).
“Xofluza is the first antiviral medicine to demonstrate a significant and clinically meaningful benefit in people at high risk of complications from the flu, for which there are currently no approved medicines,” said Sandra Horning, MD, chief medical officer and head of Global Product Development.
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Xofluza, a polymerase acidic endonuclease inhibitor, was approved in October 2018 as the first single-dose oral medicine for the treatment of acute uncomplicated influenza in patients ≥12 years of age who have been symptomatic for no more than 48 hours. A Prescription Drug User Fee Act (PDUFA) target date for the sNDA has been set for November 4, 2019.
Comment 3
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I hope the study is not one of those dubious scientific experiments financed by drug makers.
(Genentech in this case) How about 73 hours vs, 102 hours?? Is this really meaningful?
What about Tamiflu now? Are we still taking Tamiflu?
I won't be excited and go out to beat the drum until it is solidly proven to be effective in our real world.
The drug should be tried with no cost to the general public until it is proven.
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Please refer to my previous presentation No. 6270 for more on Xofluza, Baloxavir,
which was approved by FDA last October.
Both Tamiflu and Xofluza were developed by the same drug company, Roche(which owns Genentech's).
The drug company is applying now for expansion of indication, specifically for the high risk patients, i.e.
the elderly over age 65.
What is encouraging is that so far the drug seems more effective than Tamiflu and kills the virus by
entirely different mechanism as described above.
Obviously we are going to learn a lot more about this drug.
So far no study has been done by combining Tamiflu with Xofluza as far as I know.
Theoretically combining the two should be even more powerful against the viruses so one day someone will give a try.
So right now you choose either Tamiflu or Xofluza if you come down with flu.
This drug is said to be the first new anti flu virus medicine in 20 years since Tamiflu so that
there is an element of the higher expectation as far as the efficacy is concerned knowing that the same
drug company that developed Tamiflu developed this new agent.
I am trying to learn everything about it for the moment.
This is a good news for super seniors.
Every year tens of thousands of seniors die of influenza and its complications.
This drug appears to be more effective in dealing with flu virus than Tamiflu and others.
We certainly could use any additional help of any kind in fighting the flu viruses.