She said those on the state program with pre-diabetes, gestational diabetes or obesity are eligible for the drugs if deemed medically appropriate by the physician, and enrollees have to participate in a lifestyle management program. Last years legislation did not apply to the 3.9 million low-income and disabled Illinoisans enrolled in Medicaid, a population that generally struggles with obesity at higher levels than the overall population
A key differentiator of Mardrigals resmetirom is that in a pivotal Phase 3 trial, it achieved both primary endpoints of NASH resolution and reduction in fibrosis (MAESTRO-NASH), the two liver histological improvement endpoints the FDA has proposed as reasonably likely to predict clinical benefit
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This was despite some concerns outlined in briefing documents regarding Lillys trial methodology, including its use of the integrated Alzheimers Disease Rating Scale (iADRS) as the primary endpoint, the use of tau protein levels to decide study inclusion and the cessation of donanemab treatment in patients whose brain amyloid levels dropped past a certain, pre-specified threshold
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