Austin-based Savara Pharmaceuticals continues to make significant strides in bringing its impressive AeroVanc antibiotic to market for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis patients. Just last week, BioNews Texas reported on how the company bolstered its Board of Directors with top-flight biotech business development executives in a bid to further increase velocity of its AeroVanc commercialization efforts.
Today, the company has announced that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead antibiotic product, AeroVanc, as a Qualified Infectious Disease Product (QIDP), and that 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), according to a company press release.
Rob Neville, the CEO of Savara, put the FDA designations in context, commenting, “The recent QIDP status forms an important part of our market exclusivity strategy,” and adding, “This designation along with Orphan Drug status, our formulation patent protection, and our inhalation device exclusivity creates a very robust protection from competition.”
Cystic fibrosis is a disease that affects patients early in life, presents with a wide range of often debilitating symptoms, and ultimately leads to a lower quality of life and short life expectancy for those with the disease. Because a cure for the disease remains elusive and many traditional therapies only marginally effective, the FDA’s move to quality AeroVanc with the QIDP and Fast Track designation, while clearly providing Savara with certain drug development 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 — it also reveals the promising preliminary evidence that AeroVac can substantially improve quality of life for those suffering with cystic fibrosis.