Stricter data standards at the FDA could delay an approval of Amylin Pharmaceuticals' new diabetes drug, according to analysts. In a draft of new trial guidelines, the FDA outlined more tests for the macrovascular complications that could be presented by a diabetes drug. Lazard Capital Markets analyst Matthew Osborne signaled that the FDA's stance on large vein diseases particularly threatens Amylin's prospects for exenatide LAR, a long-acting version of Byetta. It could also indicate a general tightening of diabetes standards that could make the discovery process longer and more expensive.
"It appears that now the FDA will start to require of all drugs particularly for diabetes that more safety and efficacy data are generated, and how this will play out with individual agents including exenatide LAR is uncertain," he wrote. His view helped send Amylin shares down four percent.
- read the AP report