Roche flu drug proves efficacy at Phase 3, but enough to beat Tamiflu generics?
pharmafile | July 17, 2018 | News story | Manufacturing and Production, Research and Development | Roche, Tamiflu, baloxavir marboxil, flu, influenza, pharma
Roche is celebrating the news that its investigational influenza drug baloxavir marboxil performed well at Phase 3, meeting its primary endpoint and reducing symptoms in patients at a high risk of complications from the flu.
The flu presents a serious threat to global health, with three to five million severe cases emerging worldwide each year, resulting in up to 650,000 deaths. In the study, high-risk individuals were defined by criteria from The Centers for Disease Control and Prevention (CDC) as over 65 years of age or those with conditions such as asthma, chronic lung disease, diabetes, or heart disease.
In the trial, baloxavir marboxil showed superior efficacy in time to improvement of influenza symptoms compared to the combination of Roche’s own Tamiflu (oseltamivir) with placebo, as well as in secondary endpoints including reducing viral levels in the body and time that the virus continued to be released.
“Baloxavir marboxil is the first antiviral to show a clinically meaningful benefit in people who are most susceptible to complications from the flu, including older people and those living with certain medical conditions,” commented Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development. “We plan to submit the results of this second positive phase III study for baloxavir marboxil to healthcare authorities, and look forward to discussing next steps since there are no current antiviral medicines approved to specifically treat this high-risk population.”
Baloxavir marboxil is touted as the first flu medication in almost two decades to present both this efficacy and a novel proposed mechanism of action, but critics have argued that the benefits the drug has been shown to offer are only marginal compared to Tamiflu, which has seen rapidly falling sales since last year when generic equivalents began to appear on the market.
Roche’s investigational treatment is already approved in Japan, but US authorisation is within its sights; the drug has been accepted by the FDA under priority review, and it is thought a final decision could be reached by 24 December.
Matt Fellows
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