European Medicines Agency approves hypersomnia drug Sunosi (solriamfetol)
Background
The European Medicines Agency (EMA) finalized the European market approval for Sunosi (solriamfetol) on January 16, 2020. The drug was approved for the treatment of excessive daytime sleepiness and narcolepsy.
Clinical Evidence
The approval was based on clinical trial data reviewed by the EMA, which concluded that efficacy and safety were sufficiently demonstrated. Specific numerical data were not disclosed.
Competitive Landscape
Currently in Europe, modafinil and armodafinil are the primary therapies. Sunosi acts as a dopamine‑noradrenaline reuptake inhibitor, differentiating it from existing agents.
Market Outlook
The approval enables Sunosi to be marketed in all 27 EU member states. Initial revenue forecasts have not been released, but the product is expected to provide a new option in the existing hypersomnia treatment market.
Reimbursement Issues
National health authorities will assess cost‑effectiveness to determine reimbursement status. Reimbursement decisions may influence the speed of market penetration.
The EMA approval allows Sunosi to enter the European market, offering Jazz Pharmaceuticals a potential new revenue stream. Growth in the hypersomnia treatment segment is expected to drive expanded hiring for related roles.
Source: EMA (ema)