Merck Earns Approval for Drug Targeting Hospital-Acquired Infection

June 16, 2020 - Merck recently announced that the FDA approved a supplemental New Drug Application for Recarbrio, a drug targeting the source of some hospital-acquired infections.

Recarbrio is a combination of imipenem, a carbapenem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, Merck said.

The drug is intended for patients 18 years of age when treating or preventing infections that are proven or strongly suspected to be caused by susceptible bacteria.

“Hospital-acquired infections continue to be a significant cause of illness and death despite advances in our understanding of the contributing factors and prevention of these diseases,” Keith Kaye, MD, professor of medicine and director of research for the division of infectious diseases, University of Michigan Health System, and a principal investigator in the clinical program, said in the announcement. “Because these infections are often caused by difficult to treat Gram-negative organisms, new therapeutic options such as RECARBRIO are urgently needed for patients.”

The FDA approval is based on results from the Phase 3 RESTORE- IMI 2 trial that compared Recarbrio 1.25g to piperacillin/tazobactam 4.5g. Each drug was individually administered every six hours for seven to 14 days. 

Recarbrio met the primary and key secondary endpoints, demonstrating non-inferiority in 28-day all-cause mortality and clinical response at early follow-up, respectively, Merck stated. 

For patients treated with Recarbrio, 28-day all-cause mortality was 15.9 percent and 21.3 percent in those treated with piperacillin/tazobactam, for a treatment difference of -5.3 percent.

Clinical response at early follow-up was 61 percent Recarbrio and 55.8 percent for piperacillin/ tazobactam group, for a treatment difference of 5 percent. 

“At a time of great public health concern about the need for new treatments to meet the evolving challenges posed by Gram-negative bacteria, we are proud to continue bringing new therapeutic options to health care practitioners in an effort to help them overcome the challenges in patient care,” said Nicholas Kartsonis, MD, senior vice president, clinical research, infectious diseases and vaccines, Merck Research Laboratories. 

“Today’s approval is further affirmation of Merck’s steadfast commitment to meeting the needs of the health care community.”

Adults who have limited or no alternative treatment options for complicated urinary tract infections, including pyelonephritis, and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria, can also take Recarbrio, Merck said. 

The FDA approval could be a shot in the arm for Merck. The major pharmaceutical company estimated in May that the COVID-19 outbreak would decrease its revenues by over $2 billion due to social distancing and other precautions impacting business.

In the first quarter, Merck estimated that the overall impact of coronavirus on its revenue was immaterial. But company leaders anticipate a greater impact on revenues in upcoming quarters, with projected losses of approximately $1.7 billion for pharmaceuticals and $400 million for animal health products.

Nearly two-thirds of Merck’s revenue comes from physician-administered products, which are greatly being impacted by social distancing measures, fewer well visits, and delays in elective surgeries due to COVID-19, Merck noted.

Overall, the major pharmaceutical company still anticipates 2020 revenues between $46.1 billion and $48.1 billion, including a negative impact from foreign exchange of approximately 2.5 percent.