Roche: FDA grants priority review to oral flu treatment
(CercleFinance.com) - The US Food and Drug Administration has granted priority review for Roche oral antiviral baloxavir marboxil for the treatment of flu, the Swiss drugmaker said on Tuesday.
A priority review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease, Roche said.
The FDA is expected to make a decision regarding its approval by the end of the year.
Influenza results in 3 to 5 million cases of severe disease, millions of hospitalisations and up to 650,000 deaths worldwide, the company said.
If approved, baloxavir marboxil would be the first oral, single-dose antiviral drug and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years, Roche said.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
A priority review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease, Roche said.
The FDA is expected to make a decision regarding its approval by the end of the year.
Influenza results in 3 to 5 million cases of severe disease, millions of hospitalisations and up to 650,000 deaths worldwide, the company said.
If approved, baloxavir marboxil would be the first oral, single-dose antiviral drug and the first medicine with a novel proposed mechanism of action to treat the flu in nearly 20 years, Roche said.
Copyright (c) 2018 CercleFinance.com. All rights reserved.