Forbes' Matthew Herper has surveyed the scene for new cholesterol-lowering drugs and declares it a disaster zone. The FDA's decision to request Takeda to put a hold on tests of the high-dose version of TAK-475 could be an indication that the agency is holding heart pills to a higher regulatory standing. And Herper's backing up that bold remark by noting some expert opinions that link new agency draft guidance on liver toxicity as a sign that the FDA is changing the rules of the game. If Takeda is forced to limit its therapy to lower doses, they could find themselves limited to patients who don't respond to a combo therapy of currently available statins. That would be a far cry from the blockbuster market they were looking for.
- check out the report from Forbes