publication date: Dec. 8, 2017

FDA considers using data from approved indications to support regular approvals of sNDAs based on intermediate endpoints

By Matthew Bin Han Ong

FDA officials are floating a proposal for a review process informally dubbed “reverse accelerated approval.”

This mechanism would come into play in situations where the data that have already been provided to the agency may justify approval of supplemental indications.

This way, sponsors would not be required to conduct new confirmatory trials when they seek approval of supplemental new drug applications.

As it reconsiders its methodology, FDA is suggesting that additional trials are not always necessary for some supplemental indications if high-quality data already exist.

The framework is designed to expedite regular approvals for supplemental applications for drugs that may work across multiple indications. For example, historical data may be used for approving supplemental indications based on intermediate endpoints.

This approach would be especially useful in cases where there is an urgent unmet need and randomized clinical trials are not feasible. Its informal nickname notwithstanding, the process would examine all available evidence, independent of the order in which it was developed, and facilitate approval of a drug for additional uses based on an intermediate endpoint.

The agency’s review and assessment of sNDAs, is similar to the original NDA framework. … Continue reading FDA considers using data from approved indications to support regular approvals of sNDAs based on intermediate endpoints

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