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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.
Study finds reduced CIN3+ risk from early HPV vaccination
April 17th 2024A recent study found that human papillomavirus vaccination when aged under 20 years, coupled with active surveillance for cervical intraepithelial neoplasia grade 2, significantly lowers the risk of cervical intraepithelial neoplasia grade 3 or cervical cancer.
