FDA News

FDA to review Merck agents against cUTIs, cIAIs, nosocomial pneumonia

Nicholas Kartsonis, MD
Nicholas Kartsonis

The FDA has accepted a new drug application and supplemental new drug application for two Merck antibacterial agents, the company announced.

According to Merck, the agency accepted an NDA for priority review for a combination of relebactam, an investigational beta-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL) for the treatment of complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs) caused by certain susceptible gram-negative bacteria for adults who have limited or no alternative therapies.

It also accepted an sNDA for priority review for Zerbaxa (ceftolozane and tazobactam) to treat adults with nosocomial pneumonia, including ventilator-associated pneumonia caused by susceptible gram-negative microorganisms, Merck said.

Zerbaxa is currently indicated in the United States for treating adults with cUTIs, including pyelonephritis, caused by certain susceptible gram-negative microorganisms, and in combination with metronidazole for treating adults with cIAIs caused by certain susceptible gram-negative and gram-positive microorganisms, Merck noted.

“There remains an overwhelming public health need for research and development behind anti-infectives like Zerbaxa and imipenem/cilastatin/relebactam for high-need areas like gram-negative infections,” Nicholas Kartsonis, MD, senior vice present and head of clinical research for infectious diseases and vaccines at Merck Research Laboratories, told Infectious Disease News. “With the relentless, inevitable development of antimicrobial resistance to existing antibacterial agents, we must ensure that safe and effective therapies are available to treat patients today and in the future.”

The IMI/REL NDA is based on results from the phase 3 RESTORE-IMI 1 trial, which were presented at the European Congress of Clinical and Microbiology and Infectious Diseases meeting last April in Madrid. The sNDA for Zerbaxa is based on the phase 3 ASPECT-NP trial in adults with ventilator-acquired or ventilator-associated bacterial pneumonia. Merck said it plans to present the study results at a future conference.

The FDA Prescription Drug User Fee Act (PDUFA) target action date for the IMI/REL NDA is July 16, and the PDUFA target action date for the Zerbaxa sNDA is June 3, according to Merck. – by Bruce Thiel

Disclosure: Kartsonis is employed by Merck.

Nicholas Kartsonis, MD
Nicholas Kartsonis

The FDA has accepted a new drug application and supplemental new drug application for two Merck antibacterial agents, the company announced.

According to Merck, the agency accepted an NDA for priority review for a combination of relebactam, an investigational beta-lactamase inhibitor, with imipenem/cilastatin (MK-7655A, IMI/REL) for the treatment of complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs) caused by certain susceptible gram-negative bacteria for adults who have limited or no alternative therapies.

It also accepted an sNDA for priority review for Zerbaxa (ceftolozane and tazobactam) to treat adults with nosocomial pneumonia, including ventilator-associated pneumonia caused by susceptible gram-negative microorganisms, Merck said.

Zerbaxa is currently indicated in the United States for treating adults with cUTIs, including pyelonephritis, caused by certain susceptible gram-negative microorganisms, and in combination with metronidazole for treating adults with cIAIs caused by certain susceptible gram-negative and gram-positive microorganisms, Merck noted.

“There remains an overwhelming public health need for research and development behind anti-infectives like Zerbaxa and imipenem/cilastatin/relebactam for high-need areas like gram-negative infections,” Nicholas Kartsonis, MD, senior vice present and head of clinical research for infectious diseases and vaccines at Merck Research Laboratories, told Infectious Disease News. “With the relentless, inevitable development of antimicrobial resistance to existing antibacterial agents, we must ensure that safe and effective therapies are available to treat patients today and in the future.”

The IMI/REL NDA is based on results from the phase 3 RESTORE-IMI 1 trial, which were presented at the European Congress of Clinical and Microbiology and Infectious Diseases meeting last April in Madrid. The sNDA for Zerbaxa is based on the phase 3 ASPECT-NP trial in adults with ventilator-acquired or ventilator-associated bacterial pneumonia. Merck said it plans to present the study results at a future conference.

The FDA Prescription Drug User Fee Act (PDUFA) target action date for the IMI/REL NDA is July 16, and the PDUFA target action date for the Zerbaxa sNDA is June 3, according to Merck. – by Bruce Thiel

Disclosure: Kartsonis is employed by Merck.