Alogliptin, Saxagliptin Show Neutral CV Effects In Outcomes Studies
This article was originally published in Pharmaceutical Approvals Monthly
In separate trials, Takeda’s Nesina and BMS/AstraZeneca’s Onglyza demonstrated neither cardiovascular benefit nor harm in type 2 diabetics at increased risk for such events. The DPP-4 inhibitors also were not associated with increased rates of pancreatitis, which has been a safety concern for the class.
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Bristol and AstraZeneca announced mixed results from a post-marketing study for their diabetes drug Onglyza that will likely have no commercial ramifications for the drug, which has been a disappointment since its launch in 2009.
The agency announces that it is evaluating unpublished findings based on pancreatic tissue specimens from a few deceased patients; clinicians say ongoing prospective studies will determine how diabetes drugs affect the pancreas.
Takeda’s beleaguered Nesina (alogliptin) becomes the fourth DPP-4 inhibitor approved by FDA for diabetes; it remains to be seen whether the drug can find its place in a highly competitive space that continues to be controlled by Merck’s first-to-market blockbuster Januvia.