Oslo, Norway, June 13th, 2022 – AdjuTec Pharma, a privately held company developing novel antibiotic resistance breakers, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Adjutec a Qualified Infectious Disease Product (QIDP) designation to its lead product APC148 and meropenem.
The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act implemented in 2012 to give important incentives to facilitate the development of new antibacterial and antifungal drug products intended to treat serious or life-threatening infections. As part of the QIDP designation, Adjutec will gain access to certain regulatory incentives such as:
- Priority Review to the first application for which QIDP designation was granted
- Eligible for Fast Track designation, for some or all the following: (1) More frequent communication including meetings with FDA to discuss the drug’s development plan (2) Eligibility for Accelerated Approval (3) Rolling Review, meaning that a Adjutec can submit completed sections of its New Drug Application for review by FDA, rather than waiting until every section is completed
- A five-year non-patent exclusivity extension
Bjørn Klem, AdjuTec Pharma CEO, comments “The QIDP designation is a recognition from FDA of the potential value of APC148+meropenem for the US Healthcare Service. With a QIDP designation FDA is committed to fast-track development and approval of APC148+meropenem to meet the emerging threat of antimicrobial resistance. Adjutec will keep close contact with the Agency to benefit from their advice and review procedures.”
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