Dutchfella and Telepanel,

Not all FDA meetings are public. Most are not. This was the public Advisory Committee (AdCom) meeting. Not all NDA/sNDA approval decisions require an AdCom, but the FDA requested one for Vascepa. They voted 16-0 today in favor of recommending new indication (cardio) for Vascepa. However, this is not drug approval. Adcoms do not decide drug approval. The AdCom advises the FDA. Drug approval decision comes at the December 28 PDUFA date FDA meeting. FDA is not bound by AdCom recommendations. Extremely likely that Vascepa will be approved for cardio indication next month. And it will almost certainly be approved for secondary prevention (those with previous cardio event). Biggest unknown is whether label will extend to primary prevention (no prior event). There was not unanimous AdCom agreement on that issue. No big surprises today.

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