Savara Pharmaceuticals announced that the FDA has granted orphan drug status to AeroVanc (vancomycin hydrochloride inhalation powder) for the treatment of pulmonary methicillin-resistant Staphylococcus aureus (MRSA) infection in cystic fibrosis (CF) patients. AeroVanc is a proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for self-administration.
Savara is currently preparing for its Phase 2a clinical study of AeroVanc’s efficacy, to be carried out in 20 CF centers in the United States. AeroVanc has demonstrated positive safety and tolerability results in Phase 1 clinical studies conducted in healthy subjects and patients with cystic fibrosis, with a pharmacokinetic profile that supports its potential as a once- or twice-daily treatment for pulmonary MRSA infection.
Vancomycin administered by IV is the antibiotic of choice for the treatment of MRSA-related bronchopneumonia, however, IV administration, poor penetration into the lungs and systemic toxicities limit its use in a chronic setting. By delivering vancomycin directly to the site of infection, AeroVanc is expected to improve clinical efficacy and reduce adverse effects due to systemic drug exposure.
For more information visit www.savarapharma.com.