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Drugs to Watch: Market Access in Focus- Tarpeyo®and Kinpeygo®
How Orphan Drug Designation can give a small company a market edge
Tarpeyo provides a notable example of how the Orphan Drug path to market can be especially effective for smaller companies looking to achieve market access, helping streamline approval, reduce competition, and support a higher list price. Originally granted Accelerated Approval and Orphan Drug Designation (ODD) for a very specific population with a high unmet need, Tarpeyo was later given an expanded indication based on follow-up clinical trial data. In addition to broadening the potential patient population, the expanded indication extended exclusivity to 2030, giving it a 7-year boost beyond its original Accelerated Approval. However, the drug’s high price presents a potential hurdle to broad market acceptance.
This report explores:
- Disease and competitive landscape
- Market share and growth
- Adverse events
- Payer coverage
- Pricing considerations
- Patient and physician perceptions
- Patient assistance programs
