AstraZeneca's Onglyza Label Needs Revision per FDA Panel - Analyst Blog
Updates on the regulatory front are eagerly awaited by investors in the pharma/ biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and, finally, a response from the regulatory agency regarding the approval status.
Early this week, AstraZeneca plc AZN announced that 13 of the 15 Committee members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee found Onglyza to have an acceptable cardiovascular (CV) risk profile while one voted against and another abstained from voting. However, 14 of the 15 Committee members recommended that the drug's label should include new safety information about the benefit-risk profile of Onglyza and Kombiglyze XR.
The opinion rendered by the FDA panel was to a great extent expected following the concerns raised in the briefing documents ahead of the panel meeting (read more: AstraZeneca's Onglyza Briefing Documents Raise Concern).
The FDA panel’s recommendation was based on results from the SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) post-marketing study conducted to evaluate the CV effects of Onglyza when added to type II diabetes therapy in adult diabetics at risk of CV disease.
We note that 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.
AstraZeneca intends to work closely with the FDA to facilitate the approval of the supplemental new drug applications. Sales would be adversely impacted if the FDA adopts the panel’s recommendation about including new safety information in the label.
We note that the diabetes market is heavily crowded given the presence of companies like Merck MRK and Eli Lilly LLY.
AstraZeneca carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is AVEO Pharmaceuticals, Inc. AVEO carrying a Zacks Rank #1 (Strong Buy).
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