Xofluza Meets Phase 3 Study Endpoints

A pharmaceutical company announced that the phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study's primary objective.

Additionally, baloxavir marboxil showed superior efficacy in the primary endpoint of time to the improvement of influenza symptoms versus placebo.

Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the influenza A and B viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1).

Unlike other currently available antiviral treatments, baloxavir marboxil is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication.

Baloxavir marboxil also demonstrated superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released (viral shedding) and reducing viral levels in the body, said this Roche press release. 

Furthermore, baloxavir marboxil significantly reduced the incidence of influenza-related complications compared to placebo.

Baloxavir marboxil was discovered and developed by Shionogi & Co., Ltd., and is sold in Japan under the trade name Xofluza.

"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," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development.

As reported previously by Precision Vaccinations, the U.S. Food and Drug Administration (FDA) recently accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older based on the CAPSTONE-1 study and the phase II study, and is expected to make a decision on approval by 24 December 2018.

If approved, baloxavir marboxil would be the first single-dose oral antiviral, and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years.

Baloxavir marboxil was discovered by Shionogi & Co., Ltd. and is being developed globally by the Roche Group (which includes Genentech in the U.S.) and Shionogi & Co., Ltd. 

Influenza (flu) is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness. Serious outcomes of flu infection can result in hospitalization or death.

Some people, such as older people, young children, and people with certain health conditions, are at high risk of serious flu complications.

The CDC estimates that flu-related hospitalizations since 2010 ranged from 140,000 to 710,000, while flu-related deaths are estimated to have ranged from 12,000 to 56,000. 

The best way to prevent catching the flu is the influenza vaccine, says the CDC.

The CDC recommends the use of injectable influenza vaccines (including inactivated influenza vaccines and recombinant influenza vaccines).

Both trivalent (three-component) and quadrivalent (four-component) flu vaccines will be available.

These pharmacies offer several FDA approved flu vaccines.

International travelers can easily make pre-departure flu vaccination appointments at Vax-Before-Travel.

The CDC Vaccine Price List provides the private sector prices for general information.

Flu vaccine discounts can be found here.

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.