LONDON, Sept 8 (Reuters) - Bristol-Myers Squibb (BMY.N) and AstraZeneca’s (AZN.L) experimental diabetes drug Onglyza significantly improves blood sugar control when added to older medicines, researchers said on Monday.
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 NOVN.VX 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.
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 (MRK.N) Januvia, which is currently the only approved DPP-4 drug on the market.
Roland Chen, group director of global clinical research at Bristol-Myers, said he was encouraged by the findings.
“We believe the efficacy and safety profile from these studies and our programme overall is very competitive with data that has been disclosed publicly for Januvia and other DDP-4 inhibitors,” he said in a telephone interview.
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.
The commercial opportunity for the new drug class is large, since the effectiveness of older diabetes drugs is limited and they can cause unwanted side effects, like weight gain.
Januvia itself is already a blockbuster, annualising sales of $1.6 billion within two years of launch.
Dipeptidyl peptidase-4 (DPP-4) inhibitors work to enhance the body’s ability to lower elevated levels of blood sugar. Other new DPP-4 drugs in development include Takeda’s (4502.T) alogliptin. (Editing by Sue Thomas)