Williams, "After Xigris
, researchers look to new targets to combat sepsis," Nature Medicine, vol.
Following a number of high-profile cases, such as the 2010 recall of Cylert, a central nervous system stimulant to treat ADHD/ADD, and the 2011 recall of Xigris
, a treatment for severe sepsis and septic shock that was found to give patients no survival benefit, there is increased pressure to guarantee that pharmaceutical formulations are safe to use.
alfa (Fabrazyme) ** Genzyme/Sanofi Protein C (Xigris
) Lonza for Eli Lilly Factor VIII (Kogenate-FS) ** Bayer Interferon beta (Rebif) ** Merck-Serono I-2 receptor mAb (Simulect) Novartis TNF mAb (Remicade) ** Janssen/J&J FSH (Gonal-F) Merck-Serono Galactosidase.
Granted patents and pending applications in India for recombinant drugs Human insulin, Erythropoietin, Hepatitis B vaccine (recombinant surface antigen based), Human growth hormone, Interleukin 2, Interleukin 11, Granulocyte Colony Stimulating Factor (GCSF), Granulocyte Macrophage Colony Stimulating Factor (GMCSF), Interferon-2a, 2b and g, Streptokinase, Tissue Plasminogen Activator, Factor viii, Follicle stimulating hormone, Teriparatide (Forteo), Drotrecogin (Xigris
) alpha, Platelet Derived Growth Factor (PDGF), Epidermal Growth factor (EGF) and Eptacogalpha (r-F VIIa) r-coagulation factor were identified.
FDA drug safety communication: Voluntary market withdrawal of Xigris
[drotrecogin alpha (activated)] due to failure to show a survival benefit.
(drotrecogin alfa [activated]) to be withdrawn due to lack of efficacy: PROWESS-SHOCK study shows no gain in 28-day survival of septic shock patients [Press release].
[drotrecogin alfa (activated)]: market withdrawal - failure to show survival benefit.
Macias and Levy (3)--both employees of Eli Lilly and Company (the manufacturers of Xigris
)--refuted the assertions of Taylor et al.
Eli Lilly has been reported to be withdrawing activated drotreecogin alfa (Xigris
), intended to treat severe sepsis in high-risk patients, from all markets including the United States in the wake of a new study showing that the agent did no better than a placebo in reducing mortality.
M2 PHARMA-October 25, 2011-Lilly withdraws Xigris
, updates 2011 financial outlook(C)2011 M2 COMMUNICATIONS
Burton, Can Hospitals Afford Not to Prescribe Xigris