RALEIGH, N.C.--(BUSINESS WIRE)--Arrevus today announced the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) Designation for ARV-1801 (sodium fusidate tablet) for the treatment of Cystic Fibrosis Pulmonary Exacerbations.
Pulmonary exacerbations (PEx) are episodes of acute worsening of pulmonary status that occur frequently in patients with cystic fibrosis and result in a sequential and permanent decline in lung function. There is currently no therapy specifically indicated to treat PEx in the United States. “We know that ARV-1801 is one of the very few oral antibiotics that has increased potency in low pH environments and also has anti-inflammatory activity, both of which are critical to any antibiotic targeting the lungs of CF patients experiencing an exacerbation.” – commented Dr. Carl N. Kraus, M.D., Founder and CEO of Arrevus.
Dr. Donald VanDevanter, Adjunct Professor at Case Western Reserve University School of Medicine, a member of the Cystic Fibrosis Foundation’s STOP (Standardized Treatment of Pulmonary Exacerbations) initiative, and an advisor to Arrevus, stated that “having the Cystic Fibrosis Respiratory Symptom Diary and Chronic Respiratory Infection Symptom Score (CFRSD-CRISS), a validated clinical endpoint specifically designed for PEx, brings real rigor to Arrevus’s efforts in an underserved area of CF management. The proposed superiority design to evaluate ARV-1801 for PEx treatment is indicative of a strong commitment to improve outcomes for people with CF and their families, and I’m excited to support their efforts.”
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.
Arrevus develops novel therapeutics for orphan diseases that are associated with high treatment failure rates, few therapeutic options and serious outcomes.