BURLINGTON, Mass., April 23, 2014 /PRNewswire/ -- Decision Resources Group finds that two emerging therapies in late-stage clinical development—AstraZeneca/Forest Laboratories' ceftazidime-avibactam and Tetraphase's eravacycline—will replace carbapenems as preferred therapies for treatment of gram-negative infections (GNIs) due to multidrug-resistant Enterobacteriaceae following launches in 2015 and 2017, respectively. Surveyed infectious diseases (ID) specialists and hospital pharmacy directors specifically report high unmet need for new therapies active against carbapenemase-producing Enterobacteriaceae. Both of these agents offer notable improvements over carbapenems and will likely see uptake on hospital formularies and use despite the availability of generic competitors.
Importance of clinical response in evaluation of new GNI therapies: Despite the differences between the FDA's and EMA's regulatory requirements for antibacterial drug development, more than half of surveyed U.S. and European ID specialists cite clinical cure rates as being among the top most persuasive clinical trial endpoints evaluated when prescribing a new drug for GNIs due to Enterobacteriaceae.
Payer receptivity to new therapies for treatment of GNIs due to multidrug-resistant (MDR) Enterobacteriaceae: The majority ofsurveyed hospital pharmacy directors would include new GNI therapies offering improvements in both efficacy and delivery (i.e., available in interchangeable IV and oral formulations) on hospital formulary; according to survey results, these therapies could command an estimated 30 percent price premium over current branded therapies.
'Limited Population Antibacterial Drug' (LPAD) antibiotics for treatment of MDR GNIs: Nearly half of surveyed ID specialists indicate a willingness to prescribe premium-priced therapies costing up to $15,000 for a 10 to 14 day course if these agents offered significant improvements in 28-day all-cause mortality rates in patients with hospital-acquired pneumonia due to MDR Enterobacteriaceae.
Comments from Decision Resources Group Analyst Hannah E. Cummings, Ph.D.:
"Physicians are desperate for additional therapies active against MDR gram-negative pathogens, particularly in patients with nosocomial pneumonia. Mortality rates in these patients are high and treatment options are extremely limited. Despite their desire to reduce healthcare costs, physicians indicate a willingness to prescribe therapies carrying LPAD-level prices (i.e., costing up to $15,000 for a 10 to 14 day course of therapy), for new drugs that reduce mortality rates in these patients, largely because they lack alternative treatment options."
"There are few therapies available in both IV and oral formulations that retain activity against MDR gram-negative pathogens. The availability of interchangeable formulations is convenient because it allows patients to be discharged earlier, thereby reducing hospitalization costs and minimizing the risk of hospital-associated complications. Eravacycline's activity against MDR pathogens and its interchangeable IV and oral formulations will make this agent an attractive option for treatment of clinically stable patients with GNIs by facilitating discharge and use in the outpatient setting."
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