The FDA has granted Qualified Infectious Disease Product (QIDP) as well as Fast Track status designation to lefamulin, an antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), according to Nabriva Therapeutics AG, the manufacturer.
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.
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 healthcare system.
Lefamulin (BC‘3781) is about to enter Phase 3 clinical studies intended to treat CABP, plus hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP), as well as acute bacterial skin and skin structure infections (ABSSSI), with potential in several other indications, the company says.
Community-acquired respiratory tract infections, especially CABP, represent one of the main causes of morbidity and mortality among children and adults. CABP is a commonly occurring serious infection that requires systemic antibiotic therapy and is associated with considerable healthcare costs. The dominant bacterial causes are Streptococcus pneumoniae and Haemophilus influenzae, accounting for more than 80 % of CABP cases.
“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,” said Dr Colin Broom, CEO of Nabriva. “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.”