SILVER SPRING, Maryland (Reuters) Heart reserve studies should be compulsory for new obesity drugs, U.S. drug advisers pronounced on Thursday, presumably adding a new jump to a drugs approval.
An advisory row to a U.S. Food and Drug Administration voted 17-6 that regulators should make companies control heart impact studies in sequence to sell their drugs in a United States, even if clinical trials do not primarily uncover justification of increasing heart risk.
Anti-obesity drugs have a bad lane record of cardiovascular risk, pronounced Dr. Marvin Konstam, a highbrow during Tufts University School of Medicine and row member.
The FDA customarily follows row recommendations, nonetheless it is not compulsory to, and will make a final preference later.
The news could impact Vivus Inc and Arena Pharmaceuticals Inc, that are opposed to get a initial new plumpness drug to a marketplace in some-more than a decade. The FDA formerly sy...
Friday, 30 March 2012
Obesity drugs need heart studies, U.S. advisers say
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