FDA grants new QIDP Designation Status for BTX 1801
Botanix is pleased to announce that the US Food and Drug Administration (FDA) Office of Antimicrobial Products has granted new Qualified Infectious Disease Product (QIDP) status for our antibacterial product, BTX 1801.
This QDIP designation applies to the use of BTX 1901 to potentially ‘reduce the risk of Staph. aureus bloodstream infections in colonised patients dependent on central venous catheters for hemodialysis’, the lead indication for our novel intranasal gel. This represents the first such designation ever granted for a nasal decolonisation agent in this patient group.
In addition to the standard regulatory exclusivity that comes with FDA approval of a New Drug Application (NDA), QIDP offers an additional five years of regulatory exclusivity, as well as eligibility for NDA ‘priority review’ and ‘fast-track designation’ – both of which will be invaluable to Botanix’s antimicrobial development program.
Botanix President and Executive Chairman, Vince Ippolito commented:
“Botanix is very excited to receive QIDP status from the FDA. This designation is supported by our Phase 2 clinical study results and a recent health outcomes study that highlighted the impact of bloodstream infections in hemodialysis patients that use central venous catheters for access.
“These life-threatening infections in this vulnerable population are estimated to cost the health system more than $360 million annually in the US.”