In December of 2008, the Food and Drug Administration made requirements for drug companies and manufacturers to conduct studies to show that new diabetes drugs do not increase cardiovascular risk compared with current treatments. The guidance was developed amid growing concern about the safety of many diabetes drugs. AstraZeneca sponsored a trial of over sixteen thousand patients known as SAVOR previously showed patients taking Onglyza, also known as saxagliptin, had an increased risk of hospitalization due to heart failure. The company claims that it conducted the SAVOR study in accordance with the 2008 guidance and that the results met the objective of showing that patients taking Onglyza were not at greater risk as measured by a composite benchmark comprising cardiovascular death, non-fatal heart attack and non-fatal ischemic stroke.
The Food and Drug Administration’s analysis revealed that the heart failure was valid. It also showed a possible increased risk of death from all causes. The Food and Drug Administration’s review stated that, “The overall trial results did not reveal a higher death risk, but a more detailed analysis examining only patients who took the drug suggests a significantly increased risk of all-cause mortality.” The agency stated that the causes of death were often multifactorial and some patients may have had several serious medical conditions in the days and weeks prior to death. The agency state that it is not reassured by the risk, however, and does not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.
An analyst for Leerink stated that the Food and Drug Administration’s concerns over all-cause mortality were unexpected and could lead to a cut of up to 50 percent in his $1.8 billion peak annual sales estimate, if Merck & Co’s rival drug Januvia does not show similar problems.