Savara Pharmaceuticals has announced that its AeroVanc inhaled vancomycin has received Fast Track designation from the FDA and been designated as a Qualified Infectious Disease Product (QIDP) for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis patients. According to the company, the new designations will result in a priority review of the AeroVanc NDA submission and an additional five years of exclusivity after FDA approval. The product received Orphan Drug designation in 2012.
AeroVanc is currently in a Phase 2 trial for the treatment of MRSA in CF patients. The company has previously said that it expects results from that trial to be available in early 2014.
Savara CEO Rob Neville commented, “The recent QIDP status forms an important part of our market exclusivity strategy. This designation along with Orphan Drug status, our formulation patent protection and our inhalation device exclusivity creates a very robust protection from competition.”
Read the Savara press release.
