[1] While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medications and reports on them annually, first-in-class is not considered a regulatory category.
(Besponsa) (Elzonris) (Rydapt) (Tepezza) (Evenity) (Ocrevus) (Tibsovo) (Nexletol) (Vyndaqel, Vyndamax) (Oxbryta) (Zokinvy) (Dupixent) (Reyvow) (Tazverik) (Mounjaro) By definition, a first-in-class drug does not have the safety evidence from analogous products that not-first-in-class drugs would have.
[17] First-in-class drugs are often seen as commercially more attractive as they may tap into a market segment that has hitherto been underserved, but this may be illusory.
[19] A lower number of available therapeutic options correlates with higher prices.
[22] This raises ethical questions about the sustainability of the high prices on these costs.