If TLD for Excellence isn't going to be reported until 1H 2023, then Anavex must be planning to submit an NDA based on the Avatar data.
Remember, Anavex must get A2-73 approved BEFORE they can submit an NDA for their P2b/3 AD. Once A2-73 is approved for Rett, they must re-purpose the drug so that their Alzheimer's application can be accepted by the FDA. (See my post below from 1/7/22)
BTW, this may (partially) explain why it's taking so long for Anavex to release the TLD for the Avatar trial.
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abew4me Member Level Friday, 01/07/22 12:34:52 PM
Re: Gernee20 post# 343137 0
Post # of 345981
Repurposing A2-73 is extremely important for our AD application with the FDA.
And the only way we can repurpose A2-73, is if we get the drug approved.
It's my understanding that the FDA usually approves a typical NDA based on one of two criteria: The first one is having two large successful P3 trials; the other option is having one successful P3 trial along with a pre-approved drug and repurposing its use for your NDA application.
Since we only have one P3 trial going for AD, we are obviously going to use the second option. Which means we must get A2-73 approved as soon as possible...so we can repurpose its use with our AD application.
This doesn't necessarily mean that the pediatric approval is going to be delayed...because frankly, I think the Excellence (pediatric) trial will have a speedy approval on its own merits.
Below is a clip that I found in the Journal of Pharmaceutical Policy and Practice. It shows that repurposing a drug is becoming more and more acceptable by the medical community.
"Drug repurposing (i.e., using an existing drug for a new use) is essential for making the most of our medical armamentarium. Many drugs have accrued new indications over a period of years: adalimumab (Humira) was approved by the FDA for sale in 2002 with one indication and now has 10; onabotulinumtoxinA (Botox) was approved in 1989 with two indications and now has 9. Berndt et al. examine the history of uses of histamine-2 antagonists, proton-pump inhibitors, and selective-serotonin reuptake inhibitors and find that about 75% of their use was ultimately for uses other than their first-approved indications [1]. Drug repurposing has become one of the key tools in the search for medicines in the early fight against Covid-19 [2, 3], with existing products remdesivir and dexamethasone both being found to show improvements in clinical endpoints among hospitalized patients [4]."
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