THANK YOU! I’m so excited about this med. When does it come out?
Application might occur in mid 2018. It Might come out in 2019, if the FDA thinks it is safe and effective.
Wow! That’s a reasonable time frame. Thanks.
UK & EU developmental status: None
This drug will most likely be a blockbuster in the US. I guess, if it does, they will probably also want to launch it in the rest of the world. Does someone know more about international regulations and time-frames IF they decide to persue a approval in the EU? Afaik, they also needed to do clinical trials within the EU file an NDA but I’m guessing they won’t do that. Although I guess, if they do want it to bring it to the market in the EU afterwards, I’m guessing it will not be necessary start in phase I? Or does it?
thank you for posting @jamesbond
Rexulti was fda approved on july 2015. We might get it next year in Europe. So at least a 3 year delay. At least.
The thing/difference with Rexulti and Cariprazine is that it has to go through the 3 phases of trials before approval/marketing in Europe. Lumateperone has NO development-status in the EU whatsoever. The company that develops this drug purely develops it for the US-market only.
I’m guessing if this will be a blockbuster in the US, they also want to market it in the EU afterwards. However, I’m trying to find an answer on how many years of “delay” we can expect if that’s the case. And I’m unsure if it will be “only” 3 years or many(!) more.
Just like Rexulti and Cariprazine, take MIN-101 and ALKS-5461 for example, both drugs which are respectively also in phase III and phase II in Europe. If they get approval too, we can expect a delay of 3 years with the US marketing. However, with Lumateperone, it’s a whole different story because there’s no development status for the EU at all!