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38824511000001102

New Medicines

Recarbrio Bacterial infections; including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), and complicated urinary tract infection (cUTI)

Information

Recarbrio
New molecular entity
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

Launched
Launched
Approved (Licensed)
August 2020
Nov 20Licence extension for use in HAP/VAP approved in EU [20].
Oct 20Specific extension to include use in hospital acquired pneumonia recommended for EU approval by CHMP - the additional indication is "Treatment of hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), in adults (see sections 4.4 and 5.1). Treatment of bacteraemia that occurs in association with, or is suspected to be associated with HAP or VAP, in adults" [19].
Aug 20Available in the EU, Price 25 x 20ml vial=£3838.75 [16,17].
Feb 20Approved in EU [15].
Dec 19Recommended for EU approval by CHMP - the full indication is "for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options (see sections 4.2, 4.4, and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents." It is proposed that the medicine be prescribed only after consultation with a physician with appropriate experience in the management of infectious diseases [13].
Jul 19Approved in US [12].
Feb 19Granted priority review in US [11].
Jan 19Company pipeline indicates under review [10].
Nov 18Filed in EU[8].
Feb 18On company pipeline, PIII studies ongoing [6,7].
Oct 15PIII studies begin [1].

Category

Fixed dose combination of a beta-lactamase inhibitor, with a carbapenem (imipenem) and an enzyme inhibitor which blocks renal metabolism of imipenem (cilastatin). Given 6 hourly.
20 January 2016Hospital-acquired pneumonia (HAP) affects 0.5-1% of inpatients and is the most common healthcare-associated infection contributing to death. In some patients, HAP is associated with mechanical ventilation; ventilator-associated pneumonia (VAP) has a 24% to 50% mortality rate, increasing to 76% if infection is caused by multidrug-resistant pathogens. VAP accounts for up to 25% of all ICU infections [3].
Bacterial infections; including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), and complicated urinary tract infection (cUTI)
Intravenous infusion

Trial or other data

May 20PIII RESTORE-IM 2 study meets primary and key secondary endpoints. Primary endpoint of day 28 all-cause mortality was 15.9% (42/264) in patients treated with Recarbrio vs 21.3% (57/267) in PIP/TAZ group, demonstrating non-inferiority compared to PIP/TAZ [16].
Jan 19The PIII RESTORE-IMI 1 study (NCT02452047) in 50 pts with HABP, VABP, cIAI or cUTI completed in Sept 17. The percentage of pts With Favorable Overall Response [primary outcome measure] was 71.4% for the relebactam (with imipenem+cilastin) gp vs. 70% for the colistimethate (with imipenem+cilastin) gp with no signficant difference between groups. The percentage of pts experiencing ≥1 Adverse Effectss during treatment and 14-day follow-up were; 71%, 81.3% and 100% in pts receiving relebactam (with imipenem+cilastin) gp vs. 70% for the colistimethate (with imipenem+cilastin) and open label relebactam (with imipenem+cilastin) respectively [9].
Feb 18PIII study (RESTORE-IMI 2, NCT02493764) still recruting. Currently the study has an estimated primary completion date of May 2019 [6,7].
Dec 16NCT02452047 is currently recruiting patients. Collection of primary outcome data should now complete April 2017 [4].
Dec 16NCT02493764 is currently recruiting patients. Collection of primary outcome data should now complete May 2019 [5].
Jan 16PIII (NCT02452047) study is currently recruiting pts. The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (MK-7655A) versus colistimethate sodium + imipenem+cilastatin in the treatment of imipenem-resistant bacterial infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), and complicated urinary tract infection (cUTI). 64 adults will be recruited in Brazil, Colombia, Estonia, Germany, Italy, Republic of Korea, Latvia, Peru and turkey. Collection of primary outcome data should complete in Oct 16 [2].

Evidence based evaluations