FDA Panel Says Heart Data Needed For Type 2 Drugs: Advisers request long-term studies.

SILVER SPRING, MD. — A Food and Drug Administration advisory panel agreed in a 14-2 vote that developers of new drugs or biologics for type 2 diabetes should be required to conduct a long-term study evaluating cardiovascular safety or should provide “equivalent evidence” to rule out an unacceptable cardiovascular risk associated with the therapy—even in the absence of a worrisome cardiovascular safety signal in preapproval studies.