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Regulatory Focus™ > News Articles > 2020 > 6 > FDA Approvals Roundup: Recarbrio

FDA Approvals Roundup: Recarbrio

Posted 10 June 2020 | By Renee Matthews 

FDA Approvals Roundup: Recarbrio

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
Recarbrio indication extended to pneumonia
FDA has approved Merck’s Recarbrio (imipenem-cilastatin and relebactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial (HABP/VABP) pneumonia in patients aged 18 years or older.
The antibiotic was initially approved in 2019 for complicated urinary tract and intra-abdominal infections caused by susceptible gram-negative bacteria in patients who have limited or no treatment options.
The new indication for Recarbrio comes on the strength of results from the phase 3, double-blind RESTORE-IMI 2 clinical trial. The multinational study had a noninferiority design comparing Recarbrio with piperacillin/tazobactam (PIP/TAZ) in 537 adult patients HABP/VABP. Participants were randomized 1:1 to receive one of these therapies intravenously.
Recarbrio met the study’s primary endpoint, with all-cause mortality of 15.9% in patients receiving Recarbrio, compared with 21.3% in those receiving PIP/TAZ. After statistical adjustment, the treatment difference was 5.3%. A key secondary endpoint, clinical response 7-14 days after completing therapy, was also met, with an adjusted treatment difference of 5% between the study arms, favoring Recarbrio.

The supplemental new drug application was given a qualified infectious disease product designation, which is reserved for antibacterial and antifungal drug products for treating serious or life-threatening infections. As part of that designation, the application also received fast track and priority review designations.

Tags: FDA, US

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