New agent approved for late-onset Pompe disease
FDA has approved alglucosidase for patients aged 8 years and older for the treatment of late-onset Pompe disease.
FDA has approved alglucosidase alfa (Lumizyme, Genzyme) for patients aged 8 years and older for the treatment of late-onset (noninfantile) Pompe disease.
The agent was approved with a risk evaluation and mitigation strategy and will be available only through a restricted distribution system. The product labeling will also contain a boxed warning regarding an increased risk of anaphylaxis and severe allergic and immune-mediated reactions.
The approval of this agent was based on a clinical study in 90 patients aged 10 to 70 years with late-onset Pompe disease. In this study, the most common adverse events included infusion-related reactions.
Anger hurts your team’s performance and health, and yours too
October 25th 2024Anger in health care affects both patients and professionals with rising violence and negative health outcomes, but understanding its triggers and applying de-escalation techniques can help manage this pervasive issue.
