Armata Pharmaceuticals (NYSE American: ARMP) has announced that the FDA has granted AP-SA02 Qualified Infectious Disease Product (QIDP) designation for intravenous use in the adjunct treatment of complicated bacteremia caused by methicillin-sensitive S. aureus or methicillin resistant S. aureus.
The QIDP designation will provide for five years of market exclusivity and the potential for fast track and priority review.
In a statement, Dr. Deborah Birx, CEO of Armata, commented, “The FDA’s decision to grant QIDP designation to AP-SA02 underscores the urgent need for innovative antibacterial therapies to address serious and drug-resistant S. aureus infections. This designation recognizes the potential of AP-SA02 and supports our mission to advance bacteriophage-based therapies to patients with unmet medical needs through efficient, rigorously designed, randomized controlled clinical trials. We look forward to continuing to work closely with the FDA to prepare for the Phase 3 superiority study that we plan to initiate in the second half of this year.”
