Vedolizumab

I just came across this but am still at work. I'd be interested in what they said if anyone would summarize it. I read an article last night that they were close to making a decision but the data were not very favorable to prove it's safety as far as PML goes.

Here it is: http://www.businessweek.com/news/2013-12-05/takeda-s-inflammatory-bowel-drug-s-risks-questioned-by-fda-staff

"The FDA report questioned whether Osaka, Japan-based Takeda’s safety data are sufficient to prove, as the company claims, that the risk is lower in vedolizumab.



“Thus, it will be difficult to infer that one drug has a more desirable risk profile than the other; any comparisons of risk between vedolizumab and natalizumab will be crude and should be interpreted with caution,” the FDA staff wrote. "

my mom watched it today and attempted to explain it to me. they said it has a different mechanicism of action than humira and remicade. it stops the mucus membranes in the colon from being damaged by the inflammation.

Clinical trials showed vedolizumab is effective in ulcerative colitis and one trial found the drug works against Crohn’s disease while another study failed to replicate effectiveness in patients who were resistant to other treatments, according to the FDA report.

That's what scares the crap out of me. Drugs trials sponsored by the manufacturing company are typically five times more likely to show favorable outcomes. The only problem with this is when independent institutions try to verify these results, the outcomes turn out to be unfavorable. This is largely turning out to be the case with anti-depressants, biologics like humira, remicade, cimzia and other drugs like statins now.

There's no question that Vedolizumab will get approved in due time. It's just a matter of some under the table deals and some more manipulation of data to sugar coat it as the next miracle drug for UC.

Kudos to businessweek for keeping it real.

Post Edited (StealthGuardian) : 12/9/2013 8:28:37 PM (GMT-7)

I missed the Businessweek reference cause I was watching the silly Bears game, oops. Guess we have to get used to the new name of Vedolizumab, now marketed as Entyvio. FDA approval for UC may be as early as Feb18. Frightened, but hopeful.

The data from the large double-blind Gemini 1 trial showed promising results for UC patients:

At week 52, clinical remission occurred in 41.8% of patients who continued to receive vedolizumab every 8 weeks and in 44.8% of patients who continued to receive vedolizumab every 4 weeks, but in only 15.9% of patients who switched to placebo.

Happyday, I would like the info, but your email isn't available in your profile.

can you email me to? pmitra0123@gmail.com

thanks!!