15th Apr 2015 06:32
LONDON (Alliance News) - AstraZeneca PLC Wednesday said the US Food and Drug Administration has granted Orphan Drug Designation for tremelimumab for the treatment of malignant mesothelioma, while the vast majority of an FDA committee had decided that a study into saxagliptin in patients with type 2 diabetes showed an acceptable cardiovascular risk profile.
The US Orphan Drug Act provides for granting special status to a drug or biological product to treat a rare disease or condition, meaning the drug developer qualifies for development incentives like tax credits for clinical testing.
AstraZeneca's tremelimumab is an anti-CTLA-4 monoclonal antibody, and is being tested as a treatment for malignant mesothelioma, a rare, aggressive cancer that most often affects the lining of the lungs and abdomen. Currently available treatments for mesothelioma are very limited, particularly for patients with advanced disease, according to AstraZeneca.
"There is a significant need for new treatment options for patients with mesothelioma because fewer than five percent of patients currently survive beyond five years, even when they receive timely diagnosis and care. Our aim is to rapidly advance the development of tremelimumab as a potential new treatment option for these patients," said Robert Iannone, Senior Vice President, Head of Immuno-oncology, Global Medicines Development at AstraZeneca.
Tremelimumab is currently also 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 in EGFR mutated non-small cell lung cancer and with MEDI6469 in solid tumours.
Meanwhile, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 1, with one abstention, that the results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus study demonstrated that the use of saxagliptin in patients with type 2 diabetes has an acceptable cardiovascular risk profile. 14 of the 15 committee members recommended that the FDA supplement the products' labeling to add new safety information, while one member voted to withdraw saxagliptin from the market.
The Advisory Committee was asked to consider data from the study, a large, randomised, double-blind, placebo-controlled postmarketing study designed to evaluate the cardiovascular effects of ONGLYZA when added to current type 2 diabetes background therapy in adult patients with type 2 diabetes mellitus at risk for cardiovascular disease.
The study 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, AstraZeneca said.
However, the drugs giant will conduct further investigation to better understand the signal of hospitalisation for heart failure found in the study results.
The committee was convened to discuss previously submitted supplemental New Drug Applications based on the study results for ONGLYZA and KOMBIGLYZE XR. If approved, the new drug applications will provide prescribers and patients important additional information about the benefit-risk profile of ONGLYZA and KOMBIGLYZEXR, according to AstraZeneca.
The FDA is not bound by the committee's recommendations when it makes its final decisions.
By Steve McGrath; [email protected]; @stevemcgrath1
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