AstraZeneca's Onglyza Briefing Documents Raise Concern - Analyst Blog
AstraZeneca plc AZN received disappointing news with the FDA raising concerns related to the company’s diabetes drug, Onglyza (saxagliptin), in its briefing documents ahead of the review by its Endocrinologic and Metabolic Drugs Advisory Committee meeting. The FDA panel is scheduled to review the supplemental new drug application for Onglyza and Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets on Apr 14.
In its briefing documents, the FDA noted that patients when treated with Onglyza experienced a 27% increase in the risk of hospitalization due to heart failure as compared to placebo. Moreover, patients demonstrated a significant or near-significant increase in the risk of death from all causes.
AstraZeneca is looking to seek cardiovascular (CV) superiority to determine if treatment with Onglyza compared to placebo when added to current background therapy would result in a reduction in the composite endpoint of CV death, nonfatal myocardial infarction or non-fatal ischemic stroke. As per the briefing documents, Onglyza failed to achieve CV benefit compared to placebo.
These results were observed from the SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) study, conducted in type II diabetes patients with established CV disease or at a high risk of CV disease.
Onglyza was approved by the FDA in 2009 as an adjunct to diet and exercise to improve glycemic control in adults suffering from type II diabetes. The drug generated global sales of $820 million in 2014, reflecting an increase of 119% at constant exchange rate.
We remind investors that AstraZeneca boosted its diabetes portfolio by acquiring Bristol-Myers Squibb’s BMY global diabetes business in Feb 2014 thereby gaining rights to major diabetes products including Onglyza and Kombiglyze XR/Komboglyze among others.
The latest news is a disappointment considering that Onglyza is the company’s main diabetes product. Among currently prescribed treatments for type II diabetes is Merck’s MRK Januvia.
AstraZeneca carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Cytokinetics, Incorporated CYTK carrying a Zacks Rank #1 (Strong Buy).
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