Aiming for label expansion, Merck touts new trial results for antibiotic Recarbrio

You can’t accuse Merck & Co. of giving up on antibiotics. This year, it’s racked up a label expansion for Zerbaxa and a first-time approval for Recarbrio—and now it’s touting new data that could win the newcomer an expansion.

Recarbrio, a combination of imipenem, cilastatin and relebactam, met its endpoints in a phase 3 test against hospital-acquired and ventilator-associated bacterial pneumonia in adult patients, Merck said Monday.

That’s the very label expansion Merck’s Zerbaxa won earlier this year, but more antibiotic options are sorely needed for patients with severe and sometimes fatal pneumonia, said Joan Butterton, Merck’s associate vice president in infectious disease clinical research.

“When you have a patient with a bed infection, you sometimes know the infecting organism and you can test for resistance and you can see which antibiotic which will be able to fight that infection,” she said in an interview. “Many times, you need to make a decision prior to having culture and sensitivity.”

The Restore-IMI 2 study tested Recarbrio against piperacillin/tazobactam and looked at day 28 all-cause mortality and clinical response as primary and secondary endpoints. Recarbrio hit both goals in the study, and Merck now plans to file the data with regulators for approval.

Recarbrio won its initial FDA nod in July to treat complicated urinary tract and abdominal infections when other treatments don’t work.

https://www.fiercepharma.com/marketing/aiming-for-label-expansion-merck-touts-new-trial-results-for-antibiotic-recarbrio