Based on what criteria is ALS considered a rare disease?

ALS meets the European Union’s (EU) formal criteria for a “rare disease,” which is defined as having a prevalence of fewer than 50 affected individuals per 100,000 inhabitants. ALS occurs at a rate of 10 per 100,000 inhabitants, meaning it meets the aforementioned criteria for a rare disease. This formal classification is particularly significant for the development and approval of medications, which are supported by legal regulations in the EU and the United States. However, within the category of “rare diseases,” ALS belongs to the group of “common rare diseases.”