FDA Fast Tracks Merck & Co.’s Bacterial Drug RelebactamBy
Merck & Co., reports that the US Food and Drug Administration (FDA) has designated relebactam, 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.
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 II clinical trials. Merck plans to initiate Phase III studies with relebactam in combination with imipenem/cilastatin in 2015.
Source: Merck & Co.