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Roche's flu drug speeds up recovery in Phase III trial

Published on 04/10/18 at 11:34am

Swiss multinational Roche’s flu drug baloxavir marboxil significantly sped up recovery time in comparison with placebo, in people at high risk of serious complications, according to the results of a Phase III clinical trial.

If approved, the new flu treatment could be the first new drug for influenza in nearly 20 years.

“This is the first phase III trial to demonstrate a significant, clinically meaningful benefit in people at high-risk for complications from the flu for which there are no currently approved medicines.” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development.

“This study adds to the growing body of evidence supporting baloxavir marboxil as a potential first-in-class antiviral flu treatment, and we plan to discuss these data with health authorities around the world.”

The drug shortened recovery in patients at risk of serious complications such as those 65 years and older, those who have asthma and lung disease, and those who are morbidly obese or have heart conditions.

Those taking the drug recovered more than a day earlier than those receiving the placebo with a recovery time of 73.2 hours in comparison to 102.3 hours for those receiving a placebo.

The single dose, oral medicine is now awaiting approval from the FDA. The FDA is expected to make a decision on the 24th of December 2018.

Louis Goss

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