Why was Xigris pulled from the market?
Eli Lilly and Company announces withdrawal of its Xigris(R) [drotrecogin alfa (activated)] product in all markets following results of the PROWESS-SHOCK study, which showed the study did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock.
How does drotrecogin alfa works and its indications for use?
Drotrecogin alfa is similar to a natural protein produced by the body (activated protein C). In patients with severe, life-threatening bacterial infections, drotrecogin alfa decreases inflammation and the formation of blood clots in blood vessels. It also increases the breakdown of blood clots.
What is Xigris used for?
Xigris is a recombinant version of naturally occurring activated protein C. This medication has been approved for the reduction of mortality in adults with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death.
Who made Xigris?
Xigris is the current brand name of activated drotrecogin alfa, manufactured by Eli Lilly. The drug is sold in vials containing either 5 mg or 20 mg, respectively.
What is drotrecogin used for?
Drotrecogin alfa (activated) is a new therapeutic agent approved for reduction of mortality in adult patients with severe sepsis. Currently no other treatments are available or pending approval for severe sepsis. Drotrecogin alfa (activated) is a re-combinant form of human activated protein C.
Is Xigris an antibiotic?
Xigris (drotrecogin alfa) contains no antibacterial preservatives; the intravenous solution should be prepared immediately after reconstitution of the Xigris (drotrecogin alfa) in the vial(s).
When was Xigris invented?
Xigris, known generically as recombinant activated protein C or drotrecogin alfa activated, was approved by the FDA in 2001—by an evenly split vote—and was approved by the European Medicines Agency in 2002 for the treatment of severe sepsis.
What is the function of protein C?
The protein C system provides important control of blood coagulation by regulating the activities of factor VIIIa (FVIIIa) and factor Va (FVa), cofactors in the activation of factor X and prothrombin, respectively.
How much did Xigris cost?
Xigris was designed to fight sepsis, a condition that kills more than 200,000 Americans annually. It was the only approved drug for sepsis, and it costs $8,000 to treat a single patient.
How do you say drotrecogin alfa?
Pronunciation : droe-tre-KOE-gin AL-fa Latest prescription information about Drotrecogin Alfa.
What is C and S testing?
These tests measure the levels of protein C and protein S in your blood. Protein C and protein S tests are two separate tests that are often done at the same time. Protein C and protein S work together to prevent your blood from clotting too much.
What causes protein C deficiency?
Protein C deficiency is caused by alterations (mutations) in the PROC gene. The milder form is caused by an alteration in one PROC gene and is inherited in an autosomal dominant manner. The severe form is caused by an alteration in both PROC genes and is inherited in an autosomal recessive manner.