The lowdown: In the wake of the high-profile concerns in 2007 over GlaxoSmithKline's (GSK's) type 2 diabetes drug Avandia (rosiglitazone) increasing patients' risk of heart attacks, there has been considerable debate on the future of the development of products for the treatment of type 2 diabetes (Nature Rev. Drug Discov. 6, 687–689; 2007). Now the FDA's Center for Drug Evaluation and Research has produced draft guidance on the development of drugs and therapeutic biologics for the treatment and prevention of diabetes mellitus (http://www.fda.gov/cder/guidance/7630dft.htm).
Among the recommendations, the guidance suggests increasing the minimum number of patients exposed to a drug during clinical development from 1,500 to 2,500 owing to the increasing complexity of treatment regimens and the growing population of patients with type 2 diabetes. For situations in which longer periods of treatment exposure might be needed — for example, where safe alternative treatments already exist or for preventive treatment — the guidance recommends increasing long-term extensions of controlled trials by 6–12 months, and anticipates that the relevant safety information will be available on submission of the new drug application. In addition to the draft guidance, the FDA plans to hold a public advisory committee meeting to discuss new approaches for the development of new therapies for diabetes, with particular emphasis on studies to assess long-term cardiovascular risks and benefits.
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