Takeda files bowel disease drug vedolizumab in USA

I'm pretty excited that the process to get this drug approved has started.  This is my last stand drug.  If I can't get into remission on this one, I'm having surgery. 

 

http://www.pharmatimes.com/Article/13-06-24/Takeda_files_bowel_disease_drug_vedolizumab_in_USA.aspx

 http://online.wsj.com/article/PR-CO-20130621-904258.html

 

This is great news!!

ChicagoBulls11-I'm guessing we won't see this until end of 1Q2014 at the earliest. The approval process takes a while but seeing they did the largest trial ever for CD/UC maybe this will be quicker than others.  I know Simponi was submitted in July 2012 and was approved in the last couple of weeks. 

I'm a big Bulls fan. Is the 11 for BJ Armstrong?

I am going to start taking Simponi this week, which was recently FDA approved for UC. Cimzia was also another biological that was approved for UC this past quarter. Both of these medications were FDA approved for other illnesses first (like RA), I'm guessing that this makes the approval for other illnesses like UC a quicker approval process for each of these medications. Vedolizumab has not been approved for the treatment of any illness yet so the process may be more drawn out than Simponi and Cimzia.

Uceris which is a steroid was also approved recently for UC....it seems like the FDA is approving UC medications at a very fast pace; this will probably be the case going forward with other medications for UC.

We should all be very optimistic about the new medications currently available and on the horizon but the only real cure for UC is surgery. about 1/3 of all UC patients will have J-pouch surgery in our life-times. I'm under the belief that surgery is a very viable medical outcome and maybe some of us should start to consider the surgery much sooner in our fight with UC. I'm probably going surgery within 6 months; I've had enough of this disease but it is nice to have many more options than what was available to me 10 years ago when I was first Dx'd.

I'm hoping they will have an assistance program like Humira and Remicade. I have a High Deductible plan that results in my first fill of Humira every year to be $3070. Luckily the assistance plan pays all but $5 of it. Since Vedolizumab will have to be administered at an infusion center, it won't cover as much as the Humira assistance does but hopefully it covers all of the drug and just leaves us to pay for the infusion center.

Is this not a new form of tsybiri and does it carry the pml risk? Why is this good news (sorry haven't been following this)? Anyone know?

Yes, It's derived from Tysabri from what I have read but No one has developed PML in the trials and it apparently targets the gut only---unlike Tysabri...and Remi and Humira. It appears to have better results in clinical response/remission than the current biologics. Probably won't help everyone but I view it as my last best chance to save the colon.

Not sure about that. I read some articles that Takeda was hopeful that they could have the PML warning removed based on the trial results but the articles were from a couple years ago.

CGK - thanks. that seems to be what the bit of reading i've done indicates. anyone got any good links re: the safety of this (being lazy, will google it later otherwise...)

How is this different from the recently approved simponi?

From what I understand vedolizumab has an impressive safety record and is being touted as a first line therapy due to it's very good safety profile, which is much, much better than the other "biologics".