Merck’s Investigational Beta-lactamase Inhibitor Relebactam (MK-7655) Granted Qualified Infectious Disease Product (QIDP) and Fast Track Designations by FDA
September 4, 2014 8:00 am ET
Merck (NYSE:MRK), known as MSD outside the United States and Canada,
announced today 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.
About Merck
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