Ramosetron coming to US market?

[Anonymous]

Does anybody know if Astellas plans to market Ramosetron in the US any time soon? Seems like a good drug for a severely underserved market (IBS) with no safety concerns. If it ever came to the US it would potentially be in pole position to capture market share since the only other drug out there in its class (alosetron) is restricted use and can have serious side effects. Astellas took the drug through Phase II a few years back, but then apparently stopped testing it in the US and began selling it only in a few Asian countries (Japan, Korea, India, etc). Anyone know why this is and whether they plan to finish up the trials at any point?

 

[Anonymous]

Funny, I've wondered the same thing. Seeing how other IBS drugs coming onto the market are being touted as potential blockbusters (Linzess for IBS-C comes to mind), I really have no idea why Astellas is sitting on this. The only thing I can think of is the FDA was freaked out by the alosetron debacle and was wary about this class of drug. But you would think the FDA would love ramosetron precisely because it was a safe alternative.

I dunno, its possible Astellas management has some good reason, but it really gives the impression they're just incompetent and don't have their act together, prioritizing drugs with questionable efficacy over something with a proven track record in an area of need. Ramosetron could conceivably be one of their highest grossing products imo...anyone else from Astellas care to weigh in on this?

 

[Anonymous]

Funny, I've wondered the same thing. Seeing how other IBS drugs coming onto the market are being touted as potential blockbusters (Linzess for IBS-C comes to mind), I really have no idea why Astellas is sitting on this. The only thing I can think of is the FDA was freaked out by the alosetron debacle and was wary about this class of drug. But you would think the FDA would love ramosetron precisely because it was a safe alternative.

I dunno, its possible Astellas management has some good reason, but it really gives the impression they're just incompetent and don't have their act together, prioritizing drugs with questionable efficacy over something with a proven track record in an area of need. Ramosetron could conceivably be one of their highest grossing products imo...anyone else from Astellas care to weigh in on this?

Astellas will be selling Linzess in Japan.