Merck Wins QIDP And Fast Track Status For Relebactam

Merck announced that the U.S. Food and Drug Administration (FDA) has granted both Qualified Infectious Disease Product (QIDP) designation and Fast Track status to intravenous relebactam for the treatment of several infections.

Relabactam, an investigational beta-lactamase inhibitor (class A and C), is currently under assessment in combination with imipenem/cilastatin in Phase II trials. The team-up of a beta-lactamase inhibitor with a beta-lactam antibiotic may offer a way to overcome antibiotic resistance and improve antibiotics’ efficacy against infections. Results from preclinical studies show that the combination therapy showed antibacterial activity against a wide range of Gram-negative and beta-lactam-resistant pathogens.

The FDA granted QIDP designation to the drug for the treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Antibiotics in development under QIDP status gain certain incentives, which include a five-year extension of data exclusivity provisions and priority review of its New Drug Application (NDA). Fast Track status opens the door for more intensive communication with the FDA over the course of the drug development program.

“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,” said Dr. Nicholas Kartsonis, Executive Director of Infectious Disease at Merck Research Laboratories.

The company said it intends to begin Phase III development with relebactam in combination with imipenem/cilastatin next year.

Merck has recently been active in developing treatments that address infections. Earlier this year the company also initiated a late-stage trial of letermovir for the prevention cytomegalovirus (CMV) infection in bone marrow transplant patients. Merck also provided updates for its vaccine Pneumovax 23 against pneumococcal infection, as well as for Noxafil as prevention for Aspergillus and Candida infections in the EU.