Aegerion approval bodes well for ISIS, along with FASTTRACK approval for ISIS
FDA allowing FASTTRACK indicates the side effects of the vector are tolerable, in the FDA's view. Aegerion has a side effect in raising liver enzymes, seemingly identical to the EMA *excuse* for failing to approve ISIS/Genzyme. Nothing seems to be in the way for Jan 29 approval of ISIS by the FDA because the side effect cited for Aegerion, is the same for ISIS. Most importantly, and the FDA will not miss this fact, is the simple fact that ISIS is targeting a different mechanism than Aegerion. If both were used in combination and found to be tolerable, some patients may see a 2/3 reduction or 66%. That's stunning. FDA will not miss this set of facts. ISIS looks very good for approval.