AstraZeneca (AZN.L,AZN) said Wednesday that the US Food and Drug Administration or FDA Endocrinologic and Metabolic Drugs Advisory Committee or EMDAC voted 13to 1 (1 abstained; 15 total votes) that the results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus or SAVOR study demonstrated that the use of saxagliptin in patients with type 2 diabetes has an acceptable cardiovascular risk profile.
In addition, 14 out of 15 Committee members recommended that the FDA supplement the products' labeling to add new safety information, with one vote to withdraw saxagliptin from the market.
The company noted that it will also conduct further investigation to better understand the signal of hospitalisation for heart failure found in the SAVOR results.
SAVOR met the primary safety objective, demonstrating that ONGLYZA did not increase the risk for cardiovascular death, nonfatal myocardial infarction and nonfatal ischemic stroke when added to a patient's current standard of care, with or without other antidiabetic therapies, as compared to placebo.
The supplemental New Drug Applications (sNDAs) based on the SAVOR results, if approved, will provide prescribers and patients important additional information about the benefit-risk profile of ONGLYZA and KOMBIGLYZE XR.
In a separate press release, AstraZeneca announced that the US Food and Drug Administration has granted Orphan Drug Designation for the anti-CTLA-4 monoclonal antibody, tremelimumab, for the treatment of malignant mesothelioma.
Mesothelioma is a rare, aggressive cancer that most often affects the lining of the lungs and abdomen. Available treatments for mesothelioma are very limited, particularly for patients with advanced disease.
Tremelimumab is part of the broad pipeline of immuno-oncology assets being developed by AstraZeneca and its biologics research and development arm, MedImmune, which are designed to harness the body's own immune system to fight cancer. It is a fully human monoclonal antibody, which stimulates the immune system to destroy cancer cells through binding to the protein CTLA-4, expressed on the surface of activated T-lymphocytes.
In addition to being investigated as a monotherapy treatment for patients with mesothelioma, tremelimumab is currently being studied in combination with AstraZeneca's anti PD-L1 investigational immunotherapy, MEDI4736, in tumour types including non-small cell lung cancer and head and neck cancer. It is also being studied in combination with Iressa (gefitinib) in EGFR mutated non-small cell lung cancer and with MEDI6469 (a murine OX40 agonist) in solid tumours.
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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.