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In 2020, it became the only diabetic drug to be approved for reducing or preventing the risk of major cardiovascular events (MACE) in patients with type 2 diabetes

Even so, experts emphasize that micronutrient deficiencies during GLP1 therapy appear common enough to warrant proactive screening and prevention

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Based on current timelines: BLA submission Q1 2027, FDA review 1012 months under standard review, or approximately 6 months under priority review (if granted)