Factors Affecting the Price of Tryngolza(Olezarsen)

The price of Tryngolza, an antisense drug for rare familial chylomicronemia syndrome (FCS), reflects several key factors. 

Factors Affecting the Price of Tryngolza (Olezarsen)

Research and development (R&D) costs are substantial due to its niche indication, requiring specialized trials in a small patient pool, where high failure rates and lengthy clinical phases inflate expenses. Manufacturing complexity for antisense oligonucleotides, involving precise synthetic processes and strict quality control, adds to production costs. Orphan drug status grants market exclusivity, allowing developers to recoup investments through higher pricing for low - volume markets. Regulatory and compliance costs, including rigorous FDA/EMA approvals for rare diseases, further contribute. Additionally, healthcare payer negotiations in limited markets may influence final pricing, balancing access with 药企 revenue needs for ongoing rare disease innovation.