Ok, I now understand what you are asking!
I am familiar with oncology approvals rather than other therapeutic areas, so Yes, one can add a second indication as a full/regular approval (i.e. no confirmatory trials required for this specific new 2nd indication say for example, 2nd indication is supported by an RT as phase 3 pivotal with a meaningful clinical endpoint) to an existing CMA (conditional marketing authorization) with original indication still designated Conditional and commitments yet to be fulfilled.
Interestingly, which is a little puzzling to me is that the original MAA remains designated 'CMA" until the original CMA indication commitments are fulfilled! I.e. for the new fully approved 2nd indication, the EU press release might say something like "extended the current conditional marketing authorization of product xxx to include addition of a new indication xxx" without specifying the new indication was approved as regular. In the US, which is more straightforward, each indication is specifically mentioned in pkg insert/label whether its AA or regular/full approval.
Reach out privately if it is not clear!
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GRSAOnline
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Original Message:
Sent: 21-Feb-2024 22:02
From: Irache Visiers
Subject: Full approval
Hi thanks. My question is EU specific. In the EU, once you get full approval in one indication, it is not possible to add a conditional approval in a second one. Not sure if it is possible the other way around (if you have a conditional marketing authorization obtain a full approval for a separate indication while keeping the gist indication as conditional approval)
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Irache Visiers
PhD, Senior Associate Director Regulatory Affairs
Winchester MA
United States
Original Message:
Sent: 21-Feb-2024 09:19
From: Narayan Rao
Subject: Full approval
Yes, it is possible in the US! I don't see why not as long as they are two different indications or populations studied! For example in oncology, gastrointestinal stromal tumor after disease progression on or intolerance to approved therapy can be via full approval but then an indication for RCC via surrogate endpoint could be an accelerated approval i.e. aka conditional in the EU for the same molecule/product!
"I know it is not possible to add a conditional approval when you have full approval" I don't understand this statement.
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GRSAOnline
Original Message:
Sent: 21-Feb-2024 07:33
From: Anonymous Member
Subject: Full approval
This message was posted by a user wishing to remain anonymous
Hi all, I was wondering if you know the answer to this question: if a drug has conditional approval in the EU, is it possible to add a second indication with full approval while maintaining the conditional approval for the first indication? I know it is not possible to add a conditional approval when you have full approval, but I don't know the other way around. Thanks!!!