Ann: FDA RPD Designation Granted for RC220 Bisantrene, page-50

I asked ChatGPT

ME: "In a situation where a company is eligible for PRV from the FDA, based on a RPDD for a paediatric condition, does the company lose it if its drug gets approved first for an adult condition?"

ChatGPT: "No, a company does not lose its Priority Review Voucher (PRV) for a pediatric condition if its drug gets approved first for an adult condition. The PRV is awarded based on the approval of a drug for a specific condition, such as a rare pediatric disease, and is not contingent upon the subsequent use of the drug for other indications"

Here’s a detailed explanation (from ChatGPT):

Awarding of the PRV

• PRV Criteria: The FDA awards a PRV to a company upon the approval of a drug for treating a rare pediatric disease, a neglected tropical disease, or as a medical countermeasure.
• Condition-Specific: The award is based on the initial approved indication that meets the criteria for the voucher, such as a rare pediatric condition.

Use of the PRV

• Flexibility of Use: Once granted, the PRV can be used for any future new drug application (NDA) or biologics license application (BLA) that the holder chooses, regardless of the drug’s indication.
• Non-Contingent: The status of the drug’s approval for other indications, such as an adult condition, does not affect the validity or usability of the PRV.

Scenario of Approval for Adult Condition First

• Subsequent Approvals: If a drug initially developed for a pediatric condition receives approval for an adult condition first, the company still retains the PRV.
• Voucher Retention: The PRV remains valid and can be applied to expedite the review of another drug application in the future, irrespective of the first approved indication.

References

• FDA Guidelines: The FDA’s guidance documents on PRVs provide comprehensive details on the issuance, transferability, and usage of these vouchers.
• Industry Practices: Case studies and industry reports illustrate how companies strategically utilize PRVs across different drug indications without losing the voucher due to subsequent approvals.For more detailed information, you can refer to the FDA’s official guidelines on PRVs for rare pediatric diseases.