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Companies Take Aim at MRSA Infections
Methicillin-resistant Staphylococcus aureus (MRSA) is one of the most widespread and virulent nosocomial pathogens.1 MRSA is categorized as either health care-associated MRSA (HA-MRSA)2 or community-associated MRSA (CA-MRSA),3 depending on the setting where the infection was acquired. In medical facilities, MRSA may cause life-threatening bloodstream infections, pneumonia, or surgical-site infections. In the community, most MRSA infections affect the skin.4
Although MRSA remains a major patient threat, data from the Centers for Disease Control and Prevention (CDC) have shown that the rate of invasive (life-threatening) MRSA infections in health care settings is declining. Invasive MRSA infections that began in hospitals dropped 54% between 2005 and 2011, with 30,800 fewer severe infections. The study showed 9,000 fewer deaths in hospital patients in 2011 than in 2005.1
Most patients who present to U.S. hospitals with suspected MRSA infections receive empiric antimicrobial therapy before the causative pathogen has been diagnosed and confirmed. Culture-based methods are still the gold standard for detecting MRSA.5
At least 10 marketed antibiotics have demonstrated potent activity against MRSA and are used to treat invasive HA-MRSA infections in the U.S. (
The late-stage clinical pipeline for MRSA includes an array of treatments aimed at acute bacterial skin and skin-structure infections (ABSSSIs) and/or community-acquired bacterial pneumonia (
While these new treatments are expected to succeed, analysts foresee stiff competition from generic products, spurred by the loss of patent protection for two leading MRSA therapies, linezolid and daptamycin.5
Antibacterial Agents Most Commonly Used to Treat U.S. Hospital-Acquired MRSA Infections
|Ceftaroline fosamil (Teflaro)
||ABSSSIs, CABP||600 mg every 12 hours by IV infusion administered over 5–60 minutes for 5–14 days (ABSSSIs) or 5–7 days (CABP) in adults (18 years of age or older)||5–14 days: $1,831–$5,127|
||ABSSSIs, CABP, CIAIs||Initial dose: 100 mg, followed by 50 mg every 12 hours IV over approximately 30–60 minutes for 5–14 days (ABSSSIs and CIAIs) or 7–14 days (CABP)||5–14 days: $1,888–$4,977|
||ABSSSIs||Two-dose regimen: 1,000 mg IV followed 1 week later by 500 mg IV, both administered over 30 minutes||$5,364|
||ABSSSIs||1,200-mg single dose by IV infusion over 3 hours in adults||$3,480|
||ABSSSIs, HABP, VABP||
||7–21 days: M, $3,523–$10,568; F: $3,002–$9,007|
||Serious or severe infections caused by susceptible methicillin-resistant (beta-lactam-resistant) staphylococci||
||7–10 days (adults): $101–$144|
Adults with ABSSSIs (for 7–14 days):
Adults with bacteremia (for 14–42 days):
||ABSSSIs, CABP, HABP, uncomplicated SSSIs, vancomycin-resistant
|Tedizolid phosphate (Sivextro)
||ABSSSIs||200 mg once daily IV or oral over 1 hour for 6 days||
aAgents are listed alphabetically, not by preferred use. This list is not all-inclusive. Additional therapies may be available.
bBased on prescribing information; doses and schedules may vary due to patient-specific requirements.
cCosts calculated using average wholesale price for regimens in prescribing information for adults with normal kidney function, rounded to the nearest dollar.
dRepresentative dosing for sterile vancomycin hydrochloride USP (Pfizer).
ePrice calculated using weights of 88 kg for men and 75 kg for women.
ABSSSIs = acute bacterial skin and skin-structure infections; CABP = community-acquired bacterial pneumonia; CIAIs = complicated intra-abdominal infections;
CLCR = creatinine clearance; F = female; HABP = hospital-acquired bacterial pneumonia; IV = intravenous; M = male; SSSIs = skin and skin-structure infections; VABP = ventilator-associated bacterial pneumonia.
Sources: GlobalData, product prescribing information, Red Book Online
Promising Drugs in Late-Stage Clinical Development for the Treatment of MRSA Infections
||Defensin-mimetic||ABSSSIs||Phase 3||Priced at 5% premium over average daily cost of linezolid due to its first-in-class status and ability to be administered as single IV infusion; estimated cost of 7-day regimen, $2,711||2019|
|Debio 1450 (Debio 1452 prodrug)
||Fabl enzyme inhibitor||ABSSSIs||Phase 2||Priced at 25% premium over average daily cost of linezolid because of its first-in-class status and narrow spectrum of activity; estimated cost of 10-day regimen, $4,611||2020|
||Fluoroquinolone||ABSSSIs||Phase 3||Priced at 10% premium over average daily cost of ceftaroline fosamil due to its status as novel fluoroquinolone specifically indicated for MRSA and because of its oral and IV formulations; estimated cost of 10-day regimen, $3,055||2017|
||Fluoroquinolone||CABP||Phase 3 (Japan)||Priced equal to average daily cost of delafloxacin (Baxdela, Melinta Therapeutics, now in phase 3 development for ABSSSIs); estimated U.S. cost undetermined||2018|
||Systemic pleuromutilin||CABP||Phase 2/3||Priced at 20% premium over average daily cost of ceftaroline fosamil because of its first-in-class status; estimated cost of 12-day regimen, $3,999||2019|
||Aminomethylcycline (tetracycline derivative)||ABSSSIs, CABP||Phase 3||Priced at 15% premium over average daily cost of tigecycline (Tygacil, Pfizer) because of more-convenient once-daily dosing, oral and IV formulations, and improved safety profile; estimated cost of 10-day regimen, $2,741||2019|
||Fluoroketolide (macrolide derivative)||CABP||Phase 3||Priced at 5% premium over average daily cost of ceftaroline fosamil because of its next-generation macrolide status and oral and IV formulations; estimated cost of 5-day regimen, $1,458||2017|
||Fusidic acid (proprietary oral formulation)||ABSSSIs||Phase 2/3||Priced at 5% premium over average daily cost of linezolid because of its first-in-class status; estimated cost of 10-day regimen, $4,058||2018|
ABSSSIs = acute bacterial skin and skin-structure infections; CABP = community-acquired bacterial pneumonia.
Sources: GlobalData (December 2015),
- Dantes R, Mu Y, Belflower R, et al. National burden of invasive methicillin-resistant
Staphylococcus aureusinfections, United States, 2011. JAMA Intern Med 2013;173:1970–1978.
- Stefani S, Chung DR, Lindsay JA, et al. Methicillin-resistant
Staphylococcus aureus(MRSA): global epidemiology and harmonisation of typing methods. Int J Antimicrob Agents 2012;39:273–282.
- David MZ, Daum RS. Community-associated methicillin-resistant
Staphylococcus aureus: epidemiology and clinical consequences of an emerging epidemic. Clin Microbiol Rev 2010;23:616–687.
- Centers for Disease Control and Prevention. Methicillin-resistant
Staphylococcus aureus(MRSA) infections. August 42015;Available at: https://www.cdc.gov/mrsa/. Accessed January 4, 2016.
- Pace CJ, Junker M, Fu K, et al. Methicillin-resistant Staphylococcus aureus (MRSA)—Global Drug Forecast and Market Analysis to 2024 New York, New York: Global-Data. December 2015;
- Kumar K, Chopra S. New drugs for methicillin-resistant
Staphylococcus aureus: an update. J Antimicrob Chemother 2013;68:1465–1470.
- Rodvold KA, McConeghy KW. Methicillin-resistant
Staphylococcus aureustherapy: past, present, and future. Clin Infect Dis 2014;58;(suppl 1):S20–S27.