CHMP issues final diabetes guidance

EMA's CHMP issued final guidance on developing products to treat and prevent diabetes, replacing 2002 guidance. The new guidance, which is in line with an October draft, states new glucose-lowering products should show a benefit or at least an absence of harm on cardiovascular risk. The guidance also states that sponsors should prospectively define CV outcomes before Phase II testing, with an emphasis on major CV events -- CV death, non-fatal myocardial infarction and stroke. The guidance takes effect in November (see BioCentury Extra, Oct. 7, 2011). ...