New Type 2 Diabetes Drug Doesn’t Cause Same Heart Problems as Others, FDA Says

A new Type 2 diabetes drug being developed by Bristol-Myers Squibb does not appear to cause the same deadly heart-related problems as other diabetes drug, according to the Food and Drug Administration.

The drug, Onglyza, uses a chemical reaction to reduce blood sugar and is similar to Januvia, the blockbuster drug by Merk. As diabetes rates continued to rise – 23 million adult and teenaged Americans now have the condition — more and more companies are rolling out new drugs seeking to carve out a piece of a $5 billion dollar industry. Some estimates say Onglyza could earn up to $1 billion a year if approved.

The makers of Onglyza, known generically as saxagliptin, have asked the FDA to approve the drug, which is part of a new generation of diabetes drugs. The FDA is expected this week to solicit advice from an advisory panel before it considers approving the drug.

Post-Avandia: A Tougher Road to Approval for Diabetes Drugs

Ever since 2007, when the GlaxoSmithKlein diabetes drug, Avandia, was suddenly recalled after causing heart attacks and other severe complications, companies launching diabetes drugs have faced tougher scrutiny.

The FDA now requires companies to test diabetes drugs on the elderly and other high-risk patients in an effort to uncover heart problems.

However, since Bristol-Myers and co-sponsor AstraZeneca conducted their studies of Onglyza before the tougher FDA guidelines were released, their testing did not specifically address the drug’s cardiovascular risks. The FDA says there is therefore “insufficient information” on whether the drug is causing heart problems.

The companies said an analysis of data from the clinical study of Onglyza found the level of heart attacks, death, and other cardiovascular problems are within the FDA’s new safety limits. The FDA is expected this week to ask a panel of physicians if that analysis is sufficient to keep Onglyza moving forward toward approval.

Onglyza is a member of the DPP-4 inhibitor family of the diabetes medications. They block the DPP-4 enzyme, which spurs release of insulin-boosting proteins that help control blood sugar levels.

Other Diabetes Drugs on FDA Radar

Also this week, the FDA panel is expected to review another new proposed diabetes treatment from Novo Nordisk. The drug maker’s liraglutide boosts insulin while restricting the hormone GLP-1 hormone, which drives up blood sugar.

The once-daily injection would compete with Byetta, a twice-daily injectable drug in the same family of medications. An extended-release form of Byetta that would require one injection per week is now in the works. Byetta is marketed by Eli Lilly and Amylin Pharmaceutical.

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