European Medicines Agency to Review Novo Nordisk's Ozempic Due to Eye Disease Risk Concerns

The European Medicines Agency (EMA) is set to investigate concerns regarding Novo Nordisk's Ozempic due to potential risks associated with non-arteritic anterior ischemic optic neuropathy (NAION), a rare eye disease causing sudden vision loss. This decision follows an appeal from the Danish Medicines Agency, which cited two new studies suggesting a possible link between Ozempic's active ingredient, semaglutide, and NAION[1][2]. These studies include data from extensive patient cohorts in Denmark and Norway, raising sufficient concern to warrant a formal review by the European Pharmacovigilance Risk Assessment Committee. Despite these findings, NAION remains rare, and no definitive link has been confirmed, although the reports have sparked a significant review process[1][3].
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What are the implications for Novo Nordisk if the EMA finds a definitive link between Ozempic and NAION?
How does Novo Nordisk plan to address safety concerns if the investigation finds an increased risk of NAION with Ozempic use?
What measures is the EMA taking to ensure the thorough investigation of the potential link between semaglutide and NAION?
How could the reported cases of NAION in Denmark affect the future sales of Ozempic and Wegovy?
What additional research is being planned or conducted to further understand the potential adverse effects of semaglutide?