The US Food and Drug Administration (FDA) has designated Savara Pharmaceuticals’ lead antibiotic product, AeroVanc, as a Qualified Infectious Disease Product (QIDP) for the treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis patients. The company also received Fast Track designation for AeroVanc pursuant to section 506(a)(1) of the Food and Drug Administration Safety and Innovation Act (FDASIA).
The QIDP and Fast Track designation provide AeroVanc access to certain incentives, including priority review associated with a New Drug Application (NDA) submission and an additional five years of exclusivity under the Hatch-Waxman Act upon FDA approval of AeroVanc. Last year AeroVanc received orphan designation, which provides the product seven years of market exclusivity, and various other incentives.
“The recent QIDP status forms an important part of our market exclusivity strategy,” says Rob Neville, CEO of Savara Pharmaceuticals. “This designation along with Orphan Drug status, our formulation patent protection and our inhalation device exclusivity creates a very robust protection from competition.”
Savara Pharmaceuticals is currently conducting a nationwide phase II clinical trial evaluating the safety and efficacy of AeroVanc in CF patients.
Vancomycin is an FDA-approved intravenously administered antibiotic with proven efficacy in the treatment of MRSA infections. AeroVanc is an investigational, proprietary inhaled dry powder form of vancomycin in a capsule-based device designed for convenient self-administration. AeroVanc is currently being developed as a treatment for persistent MRSA lung infection in CF patients. By delivering vancomycin directly to the lungs, higher vancomycin concentrations are achieved at the site of infection, which is expected to lead to improved clinical efficacy. In addition, direct delivery of the drug into the lungs reduces exposure to the drug elsewhere in the body, and is thereby expected to reduce the risk of systemic drug-related side effects.
Savara Pharmaceuticals is a specialty pharmaceutical company developing AeroVanc (vancomycin hydrochloride inhalation powder), the first dry powder inhaled antibiotic for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infection in patients with cystic fibrosis.