Abbott Laboratories’ run of mixed product news continued after the results of the SURVIVE study found that its heart failure drug Simdax (levosimendan) failed to show a significant improvement in survival.
SURVIVE, also carried out in very sick heart failure patients, found that Abbott’s drug was unable to meet the target of a 25% reduction in mortality compared to the comparator drug dobutamine. However, Simdax-treated patients showed a trend towards improved survival – about an 8% improvement over dobutamine - over the course of the six-month study.
The lead investigator in the study said that Simdax did appear to confer some benefit in this particularly ill group of heart failure patients, mainly in the first couple of weeks of treatment.
Earlier this week Abbott saw its shares on the slide after Simdax was associated with a trend towards worse survival when added onto standard therapy in patients with acute decompensated or worsening heart failure, the same group tested in SURVIVE, although the drug did seem to improve clinical symptoms. It also had a disappointment when a trial of Tricor (fenofibrate) failed to meet its objective of improving survival in diabetics with lipid abnormalities.
The data increase the height of the regulatory hurdle that Abbott will have to vault over in order to secure approval for Simdax in the USA, although the product, originally developed by Finland’s Orion Pharma, is already approved in 40 other countries worldwide.
Analysts said that the US Food and Drug Administration (FDA) had already been expected to scrutinize Simdax carefully, in light of the post-marketing safety issues that emerged with Johnson & Johnson’s Natrecor (nesiritide), now restricted for use only in the most severely ill heart failure patients.
The SURVIVE data were presented November 16 at the late-breaking clinical trials session of the American Heart Association annual meeting.