Bristol-Myers Squib and AstraZeneca’s experimental diabetes drug Onglyza significantly improves blood sugar control when added to older medicines, researchers said at EASD.
There were no reports of skin lesions in the latest clinical trial results — a potential problem with so-called DPP-4 diabetes drugs — but there were signs Onglyza increased blood pressure when added to established sulfonylurea treatment.
Onglyza, also known as saxagliptin, has already been filed for U.S. and European regulatory approval and could, in theory, be approved by the U.S. Food and Drug Administration in April next year.
Many analysts, however, are concerned it might end up being subject to regulatory delays similar to those seen with Novartis’s Galvus, which has not been launched in the United States due to skin and kidney safety concerns. Both Onglyza and Galvus were linked to skin lesions when given in high doses in pre-clinical tests to primates.
Results of Phase III studies presented at the European Association for the Study of Diabetes annual meeting in Rome showed Onglyza improved all measures of glucose control — HbA1C, fasting plasma glucose and postprandial glucose — when added to a sulphonylurea or a thiazolidinedione drug.
The companies submitted a New Drug Application to the U.S. Food & Drug Administration (FDA) on June 30, which has been officially filed by the FDA, and a Marketing Authorization Application to the European Medicines Agency (EMEA) on July 1, which has been accepted for review by the Agency. The submissions are based on data from a comprehensive clinical trial program conducted in addition to standard therapies, as well as in treatment naïve patients as a monotherapy. The clinical trial program included studies that evaluated the drug at up to 80 times the proposed usual clinical dose of 5 mg, once daily. The six core Phase III trials assessing the safety and efficacy of saxagliptin involved more than 4,000 patients, including 3,000 who were treated with saxagliptin. The companies have proposed the name ONGLYZA which, if approved by the FDA and the EMEA, will serve as the trade name for saxagliptin.
Similar improvements were also seen when Onglyza was added to a third drug class, metformin, according to an abstract for another study to be presented on Tuesday.
Overall, industry analysts said the new drug appeared to show comparable efficacy to Merck & Co’s Januvia, which is currently the only approved DPP-4 drug on the market.
Cases of raised blood pressure seen in the sulphonylurea combination study were all mild to moderate, with no patients needing to drop out of treatment as a result, he added.
Januvia itself is already a blockbuster, annual rising sales of $1.6 billion within two years of launch.
The Lancet, news release, Sept. 7, 2008
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