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ZURICH (Reuters) – Baloxavir marboxil, an influenza drug, has significantly relieved patients who are extremely vulnerable to serious complications, a top-of-the-line clinical trial said Thursday, according to Swiss drug maker Roche.
FILE PHOTO: The logo of the Swiss drug manufacturer Roche is visible at its headquarters in Basel, Switzerland, on February 1, 2018. REUTERS / Arnd Wiegmann / File Photo
If approved, it would be the first new method of treating flu for nearly two decades, Roche added.
The CAPSTONE-2 phase III trial showed median time to symptom improvement over placebo increased from 102.3 hours to 73.2 hours for at-risk patients, including the elderly age 65 and over and those with asthma, chronic lung disease, morbid obesity or heart disease.
The single-dose oral drug – discovered and developed by Shionogi & Co Ltd and sold in Japan as Xofluza – is the first to show such benefits, Roche said in a statement.
The drug was well tolerated and the trial did not emit any new safety signals.
"This study adds to the growing body of evidence supporting baloxavir marboxil as first-line influenza antiviral therapy, and we plan to discuss this data with health authorities around the world," said Sandra Horning, MD. Chief of Roche.
The US Food and Drug Administration has given priority to reviewing the drug in people aged 12 and older based on the results of previous studies, Roche said. On December 24, he should decide whether to approve it or not.
Michael Shields report; edited by Brenna Hughes Neghaiwi
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