RALEIGH, N.C.--(BUSINESS WIRE)--Arrevus, a clinical stage biopharmaceutical company committed to the development of innovative therapies to treat orphan or serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ARV-1801 for the treatment of cystic fibrosis (CF). Orphan Drug Designation provides for close guidance by the FDA, potentially accelerating time to marketing approval and also includes the potential for orphan drug grants, tax credits, and 7-year market exclusivity upon marketing approval.
"Orphan drug status is granted to clinical stage therapies targeting conditions that affect fewer than 200,000 patients in the United States. Cystic fibrosis patients have limited oral options to treat the frequent infections they encounter. 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.
ARV-1801 (sodium fusidate) is an oral antibiotic that is highly active against antibiotic-resistant strains of S. aureus (MRSA). The ability of sodium fusidate to eradicate MRSA in CF patients is well-established outside the United States. Decolonization protocols in the UK and Australia include sodium fusidate as a first line agent in the treatment of MRSA.
"At the end of the day, what drives disease progression and kills people with cystic fibrosis are infections that become resistant to currently available anti-infective treatments. As our disease advances, we run out of antimicrobial tools to treat the infections ravaging our lungs. We are in dire need of new oral and inhaled anti-infective treatments, particularly for certain pathogens for which we have very limited oral and inhaled antibiotics to treat, including MRSA," said Emily Kramer-Golinkoff, Co-Founder of Emily’s Entourage (www.emilysentourage.org) and an individual with cystic fibrosis.
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 US for bacterial decolonization in cystic fibrosis patients.
Arrevus develops novel therapeutics for orphan or serious diseases.