Posted by Michael Wonder on 03 Feb 2020
Arrevus Receives FDA qualified infectious disease product designation for the treatment of cystic fibrosis pulmonary exacerbations
28 January 2020 - Arrevus today announced the U.S. FDA has granted qualified infectious disease product designation for ARV-1801 (sodium fusidate tablet) for the treatment of cystic fibrosis pulmonary exacerbations.
ARV-1801 (sodium fusidate) is the only member of the fusidane class of antibiotics that is available globally and is considered a new molecular entity in the United States.
Arrevus is planning to initiate a phase 2 study to examine ARV-1801 in the treatment of pulmonary exacerbations in patients with cystic fibrosis. Sodium fusidate is included in multiple treatment guidelines outside of the U.S. for bacterial decolonization in cystic fibrosis patients.
