OR WAIT null SECS
ABBOTT PARK, Ill. -- A heart failure drug called levosimendan (Simdax), which has been in clinical trials, has been withdrawn from development by Abbott Laboratories and Finnish partners.
ABBOTT PARK, Ill., May 2 -- A heart failure drug called levosimendan (Simdax), which has been in clinical trials, has been withdrawn from development by Abbott Laboratories and its Finnish partners.
In the 1,327-patient SURVIVE study (Survival of Patients with Acute Heart Failure in Need of Intravenous Inotropic Support), levosimendan did not to significantly increase survival compared with dobutamine.
The SURVIVE findings, first reported at the American Heart Association meeting in 2005, have just been published in the May 2 issue of the Journal of the American Medical Association.
All-cause mortality was 26% in the levosimendan arm versus 28% in the dobutamine arm despite the fact that levosimendan treatment was associated with a significant decrease in B-type natriuretic peptide at 24 hours and persisting for five days (P<0.001).
In a statement, Abbott said that further development of the drug was not "commercially reasonable" because the FDA demanded additional phase III trials as a condition of approval.
Levosimendan is licensed in more than 40 countries but is not yet approved in England, France, or Germany.