Yes, you can still use the same LD for the new indication and the 505b2 pathway may still be appropriate, but since the indication is different than the one for which the LD is approved, you cannot rely upon the Agency's previous findings of efficacy for the LD to support your NDA. However, depending on your product's route of administration and bioavailability relative to that of the LD, you may still be able to rely upon the Agency's previous findings of nonclinical safety, clinical pharmacology, and clinical safety. So, assuming you can establish a scientific bridge to the LD, you could still be able to have a shortened development program using the 505b2 approach, but you will need a Phase 3 efficacy study. Whether you need 1 or 2 AWC studies is for you to discuss with the FDA, but considering the related indications you may be able to leverage the LD efficacy data to support conducting only 1 AWC efficacy study of your product.
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Marissa Berry, Ph.D., RAC
Senior Manager, Regulatory Strategy
Durham, NC
United States
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Original Message:
Sent: 01-Feb-2023 18:11
From: Anonymous Member
Subject: RLD for a 505(b)(2) pathway for a new indication
This message was posted by a user wishing to remain anonymous
Hi,
We are developing a treatment for postpartum depression via the b2 pathway and have a RLD identified which has been approved for the same indication. We wish to study another indication (as an example major depressive disorder) for which the above mentioned RLD is not approved (not indicated). Can you use the same RLD for the new indication, given that "depression" is a broader umbrella indication? Will the b2 pathway continue to be appropriate/valid? Thanks.