Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has designated relebactam (previously known as MK-7655), the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with designated Fast Track status. The QIDP and Fast Track designations apply to intravenous use of relebactam for the treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.
QIDP designation, provided under the Generating Antibiotic Incentives Now (GAIN) Act, offers certain incentives for the development of new antibiotics, including a five-year extension of the data exclusivity provisions under the Hatch-Waxman Act and priority review of the New Drug Application when filed. Fast Track designation provides for enhanced communication with the FDA during the drug development program.
“The lack of new medicines to fight drug-resistant infections is a growing public health concern,” said Dr. Nicholas Kartsonis, executive director, Infectious Disease, Merck Research Laboratories. “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.”
Beta-lactamases are a family of enzymes produced by some bacteria that can cause resistance to several widely used beta-lactam antibiotics, including penicillins, cephalosporins and carbapenems. By combining a beta-lactamase inhibitor with a beta-lactam antibiotic, it may be possible to overcome the resistance and extend the spectrum of activity of the antibiotic to fight infections.
Relebactam is an investigational, class A and C, beta-lactamase inhibitor that is being evaluated in combination with imipenem/cilastatin in ongoing Phase 2 clinical trials for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. In preclinical studies, relebactam administered in combination with imipenem/cilastatin demonstrated antibacterial activity against a broad range of Gram-negative and beta-lactam-resistant pathogens. Merck plans to initiate Phase 3 studies with relebactam in combination with imipenem/cilastatin in 2015.
Date: September 4, 2014