The US Food and Drug Administration (FDA) has accepted a new drug application (NDA) and awarded priority review designation to Roche’s baloxavir marboxil for the treatment of influenza.
Baloxavir marboxil is indicated as a single-dose, oral therapy for patients aged 12 years and above suffering from an acute, uncomplicated form of the infectious disease.
The investigational drug is formulated to act against the flu virus by blocking the cap-dependent endonuclease protein, which is present within the virus and is required for its replication.
Although Japanese pharmaceutical company Shionogi discovered baloxavir marboxil, Roche is developing the product globally under an agreement signed between the companies.
Roche Global Product Development chief medical officer and head Sandra Horning said: “The severity of the recent flu season underscores the need for new options beyond currently available treatments and, if approved, baloxavir marboxil would be the first flu medicine with a novel proposed mechanism of action in nearly 20 years.”
The NDA submitted to the FDA includes data obtained during the Phase III CAPSTONE-1 clinical trial conducted to assess the efficacy and safety of twice daily baloxavir marboxil for five days in 1,436 US and Japanese flu patients who were otherwise healthy.
During the multi-centre, randomised, double-blind, placebo-controlled trial, baloxavir marboxil met both primary and secondary endpoints with a favourable tolerability profile.
The investigational candidate is being further evaluated in a Phase III development programme, which also includes paediatric populations with influenza.
Baloxavir marboxil is already approved in Japan to treat both paediatrics and adults with influenza types A and B.