A prominent medical expert, Cardiologist Steven Nissen of the Cleveland Clinic urged the U.S. Food and Drug Administration to raise its standards for approving diabetes drugs on Tuesday. Nissen said that companies need to prove new drugs don’t increase cardiovascular disease, the leading killer of diabetics. Nissen suggested that, in addition to requiring more pre-approval studies, companies should have large, long-term studies in place when a drug is approved to monitor whether the drug increases the risk of cardiovascular disease. He discussed the issue of diabetes drugs standards as a part of a two-day meeting starting Tuesday.
Companies like Bristol-Myers Squibb Co. (BMY) and AstraZeneca PLC (AZN) are seeking FDA approval for diabetes drugs. All these are likely to be effected by new changes in the procedure. The other companies that are likely to be effected by the change include; GlaxoSmithKline PLC (GSK) and Takeda Pharmaceutical Co. (4502.TO).
The issue of diabetes drugs standards is part of a two-day meeting starting Tuesday. The meetings were prompted in part by controversies about research on cholesterol-lowering drug Vytorin and Avandia, a diabetes drug. A study last year shows that the life spans of the diabetes drug Avandia didn’t improve because of the increased risk for heart attack.
Some of the doctors emphasized the importance of lowering blood sugar in preventing blindness and other major problems associated with diabetes. Robert Ratner said about 55 diabetics a day become blind. He shows the records of the Center for Disease Control and Prevention data.
Filed under Diabetes, Diabetes Drug | Tags: Avandia, Bristol-Myers Squibb Co., cardiovascular disease, Center for Disease Control and Prevention data., Cleveland Clinic, Food and Drug Administration, GlaxoSmithKline PLC, Vytorin | Comment Below