Nabriva Therapeutics AG, a biotechnology company focused on developing pleuromutilins, a new class of antibiotics for the treatment of serious infections caused by resistant Gram-positive and Gram-negative pathogens, announced today that the United States Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) as well as Fast Track status designation to Nabriva's lead product lefamulin, for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
The FDA's Fast Track program allows an expedited review facilitating the development of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The QIDP designation allows five extra years of market exclusivity for antimicrobials designed to treat serious and life-threatening infections. These designations have been granted to lefamulin used for the treatment of CABP and ABSSSI. It is estimated that five to 10 million cases of CABP in the US lead to 1.1 million hospitalizations and 45,000 deaths annually. ABSSSI are among the most common infections requiring hospitalization and exert a substantial burden on the health care system.
Dr Colin Broom, Chief Executive Officer of Nabriva, commented on the news: "There is a serious and growing public health threat as a result of the rise in increasingly difficult-to-treat bacterial infections. The FDA's QIDP and Fast Track designations are validation of Nabriva's approach and underlying science to develop a truly novel antibiotic product able to address significant unmet need. Nabriva is establishing its US office and clinical development team in Philadelphia and is focussed on advancing lefamulin to phase 3 trials, for an initial indication in CABP."