New Antisepsis Drug Breaks Therapeutic Ground
New Antisepsis Drug Breaks Therapeutic Ground
Suppose a first of its kind medicine was approved that would save an estimated 45,000 patients with the most severe cases of sepsis each year? But what if there were a total of 750,000 such cases of sepsis annually, so that only 1 out of every 16 patients benefited from this therapy? Now suppose the cost were high ($6,800 for a 96-hour treatment for 70 kg patient). What effect could such a drug have on hospital budgets already stretched to the limit? Or would the lives saved justify the costs? Those exact questions define the dilemma that first split an FDA advisory committee and are now being addressed by pharmacy and therapeutics committees at hospitals across the nation about Lilly's new sepsis drug drotrecogin alfa (activated) (Xigris), a recombinant form of human activated protein C.
The agent is the first in a completely new therapeutic category of medications for this life-threatening condition. Activated protein C is thought by many experts in the field to be critically important in the detrimental cascade that produces septic shock.
As with many new drug applications, drotrecogin alfa (activated) has had its share of challenges.
Despite the optimism of Lilly and the financial world, when it came time for marketing approval, the FDA advisory committee split 10-10 over the agent at an October meeting. A month later, drotrecogin alfa (activated) was approved by FDA and became the first and only medication indicated specifically for treatment of severe sepsis.
(Enlarge Image)
New molecular entity approvals since 1993. *Through December 19, 2001 Source: CDER Report to the Nation: 2000 (www.fda.gov/cder/reports/RTN2000/Graphics/Report2000/img003lg.jpg).
Suppose a first of its kind medicine was approved that would save an estimated 45,000 patients with the most severe cases of sepsis each year? But what if there were a total of 750,000 such cases of sepsis annually, so that only 1 out of every 16 patients benefited from this therapy? Now suppose the cost were high ($6,800 for a 96-hour treatment for 70 kg patient). What effect could such a drug have on hospital budgets already stretched to the limit? Or would the lives saved justify the costs? Those exact questions define the dilemma that first split an FDA advisory committee and are now being addressed by pharmacy and therapeutics committees at hospitals across the nation about Lilly's new sepsis drug drotrecogin alfa (activated) (Xigris), a recombinant form of human activated protein C.
The agent is the first in a completely new therapeutic category of medications for this life-threatening condition. Activated protein C is thought by many experts in the field to be critically important in the detrimental cascade that produces septic shock.
As with many new drug applications, drotrecogin alfa (activated) has had its share of challenges.
Despite the optimism of Lilly and the financial world, when it came time for marketing approval, the FDA advisory committee split 10-10 over the agent at an October meeting. A month later, drotrecogin alfa (activated) was approved by FDA and became the first and only medication indicated specifically for treatment of severe sepsis.
(Enlarge Image)
New molecular entity approvals since 1993. *Through December 19, 2001 Source: CDER Report to the Nation: 2000 (www.fda.gov/cder/reports/RTN2000/Graphics/Report2000/img003lg.jpg).
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