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The same FDA document mandates post-marketing trials to demonstrate that the novel agent does not increase cardiovascular risk by more than 30% compared to placebo (henceforth these trials were named cardiovascular outcome trial), if premarketing studies did not already demonstrate this
One such condition is Glutathione Synthetase Deficiency (GSD), a rare metabolic disorder that can present with severe symptoms
RELB, IRF5, and JUNB, which drive neutrophil effector responses
The injection takes less than 30 seconds and uses a thin needle comparable to diabetic insulin pens, making it simple to self-administer at home, work, or travel
In 2024, the FDA added a cardiovascular indication after a major outcomes study showed fewer serious heart problems in higher-risk patients with overweight or obesity
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