FDA grants fast track status to relebactam for complicated UTIs

Merck today announced that the FDA has designated its antibiotic relebactam as a qualified infectious disease product, or QIDP, with fast track status, which will expedite the approval process of the drug for the IV treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

“The lack of new medicines to fight drug-resistant infections is a growing public health concern,” Nicholas Kartsonis, MD, executive director of infectious disease at Merck Research Laboratories, said in a press release. “We are pleased that the FDA has designated relebactam as a QIDP with fast track status, and we look forward to working with the FDA and other experts in infectious disease to study this medicine with the goal of bringing it to people suffering from potentially life-threatening resistant bacterial infections as quickly as possible.”

Under the 2012 Generating Antibiotic Incentives Now (GAIN) Act, QIDP designation will give Merck a 5-year extension of market exclusivity should the FDA approve the antibiotic.

Relebactam, a beta-lactamase inhibitor, is being evaluated in combination with imipenem/cilastatin (Primaxin, Merck) in phase 2 clinical trials for the treatment of complicated UTIs and complicated intra-abdominal infections. When administered in combination with imipenem/cilastatin, relebactam demonstrated activity against a range of gram-negative and beta-lactam–resistant infections in preclinical studies, according to Merck.

Phase 3 studies of relebactam combined with imipenem/cilastatin are planned for 2015.