The Food and Drug Administration has granted Orphan Drug designation to ARV-1801 (sodium fusidate; Arrevus) for the treatment of pulmonary exacerbations in patients with cystic fibrosis.
Sodium fusidate is an oral antibiotic that is effective against methicillin-resistant Staphylococcus aureus (MRSA) and has been found to have anti-inflammatory and mucolytic properties. It is included in multiple treatment guidelines outside of the US for bacterial decolonization in cystic fibrosis patients, but is considered a New Molecular Entity in the US.
The Company is planning to initiate a phase 2 study evaluating the antibiotic therapy for the treatment of pulmonary exacerbations in patients with cystic fibrosis. Orphan Drug designation allows for closer FDA guidance and the possibility of an accelerated time to approval and 7 year market exclusivity.
“We are thrilled to have FDA’s support and we will continue our efforts to bring ARV-1801 to cystic fibrosis patients,” said Carl N. Kraus, MD, President and CEO of Arrevus.
In patients with cystic fibrosis, persistent Staphylococcus aureus infection can lead to a progressive reduction in lung function, with significantly more damage possible when MRSA is involved.
For more information visit arrevus.com.