The FDA has designated Motif Bio’s novel antibiotic iclaprim as a Qualified Infectious Diseases Product (QIDP).
QIDP designation is used to help incentivise production of new antibiotics, and makes icalrpim eligible for priority review and fast track designation, as well as 10 years of market exclusivity.
The drug is a broad-spectrum antibiotic designed to be effective against multi-drug resistant bacteria. Such treatments are key to combatting the growing threat of antimicrobial resistance (AMR), which is predicted to cause up to 10 million extra deaths a year by 2050 if a solution is not found soon.
Motif, which specialises in novel antibiotics, says it believes iclaprim is the first drug in the dihydrofolate reductase inhibitor class to receive QIDP designation.
The new designation covers the indications of acute bacterial skin and skin structure infections (ABSSSI) and hospital acquired bacterial pneumonia (HABP), two of the most common and serious forms of bacterial infection.
This includes illnesses caused by prevalent resistant strains such as MRSA (methicillin-resistant Staphylococcus aureus) and MDRSP (multi-drug resistant Streptococcus pneumoniae).