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Results from a Phase 3 clinical trial, CAPSTONE-2, evaluating Genentech's Balboxavir Marboxil at Roche (OTCQX: RHHBY) in patients at high risk of influenza-related complications have shown therapeutic benefits. The data was presented at IDWeek in San Francisco.
Patients at high risk (those over 65, asthmatics, chronic lung disease, morbid obesity, or heart disease) receiving baloxavir marboxil, an orally-developed and orally-developed antiviral, were significantly reduced in symptoms compared with the control (median 73%). 2 hours versus 102.3 hours, p <0.0001).
The improvement time of flu-like symptoms favored baloxavir marboxil compared to Tamiflu (oseltamivir phosphate) (median 73.2 hours vs 81.0 hours), but the difference was not statistically significant.
Baloxavir marboxil also demonstrated its superiority over control and oseltamivir over key secondary endpoints, including the reduction of viral shedding and the reduction in the number of complications related to influenza.
Genentech has signed an agreement with BARDA to provide funding to support the development of baloxavir marboxil in critically ill hospitalized patients with influenza.
The company's marketing application in the United States is currently under review by the FDA with an action date set for December 24th.
Previously: Roche's antiviral balovavir marboxil was a success in an advanced phase study (17 July)
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