Showing posts with label new treatment. Show all posts
Showing posts with label new treatment. Show all posts

Friday, December 20, 2013

#Vedolizumab - Favorable Among FDA for Ulcerative #Colitis & #Crohns

Good News!!  The FDA supports the approval of Vedolizumab for the treatment of Crohn's disease and ulcerative colitis.  The treatment looks extremely promising with a safety profile to be recognized.  
Hey, If I would consider the treatment, it has to have minimal/low risks in regard to serious side effects that a lot of biologics have.  Vedolizumab is looking good in the safety department.
The FDA will make the decision to either approve or deny treatment for use among ulcerative colitis (UC) patients by Feb. 18.  The decision for Crohn’s disease (CD) patients will be several months later around June. 




SILVER SPRING, Md. -- Most members of an FDA advisory committee support approval of the investigational biologic agent vedolizumab for Crohn's disease, as well as supporting an additional indication for ulcerative colitis.

Tuesday, October 01, 2013

Vedolizumab, A New Treatment for Ulcerative Colitis & Crohn's Disease Looks Promising - Info & Clinical Trial Included

Vedolizumab, a potentially new treatment for UC and Crohn's disease is being fast tracked for review by the FDA.  The BLA (biologics license application) will give priority review to the ulcerative colitis application and standard review to the Crohn's disease application.
The part of the clinical trial that is most important to me is the said adverse effects that were found in the patients who participated in the study.  Based on the concluding trial results, the adverse effects of the drug is said to be the same as the placebo.  That's great news.  I'm going to continue to watch this drug for new updates and news pertaining to safety. So far, this new treatment by Takeda Pharmaceuticals looks promising.
I have also included the clinical trial abstract below.  

On Sept. 4, Takeda Pharmaceutical Company Ltd., announced that it received priority review status from the FDA for its drug vedolizumab, an investigational antibody for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). Takeda submitted a biologics license application (BLA) to the FDA in June for the treatment of CD and UC; the UC application will receive priority review, and the application for CD will be reviewed under the standard timeline.