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.
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.
In the closest vote of the Gastrointestinal Drugs and Drug Safety and Risk Management joint advisory committee meeting, the members voted 12-9 in favor of recommending approval of the drug for its Crohn's indication as an induction therapy, while the panel voted 20-0, with one abstention, to greenlight the drug as a maintenance therapy for the condition.
"While the data for Crohn's disease don't appear quite as strong, there does appear to be some efficacy and particularly the 10-week data were compelling," noted panelist Linda Feagins, MD, of the University of Texas Southwestern Medical Center in Dallas. She added that "the need for other treatment for Crohn's disease is great and we see that every day treating our patients, and I feel that doing further trials and holding this for patients will increase costs and delay drug availability."
Because the meeting was delayed by 2 hours due to inclement weather, the panel announced early in its Monday session that it would skip a formal vote on the ulcerative colitis indication, citing overwhelming evidence in its favor.
Vedolizumab's manufacturer, Takeda Pharmaceuticals, submitted the drug for approval for the Crohn's disease and ulcerative colitis patient population who had moderate to severely active disease and who were inadequately treated with, did not respond to, or were intolerant of convention therapy or a tumor necrosis factor-alpha antagonist.
Phase III trial data showed the drug was effective in ulcerative colitis patients, but only one of two trials showed drug efficacy at 6 weeks for Crohn's disease. However, data presented during the panel meeting out to 52 weeks of treatment showed significant improvements in remission rates among those who received drug treatment for 4 and 8 weeks.
Another issued raised prior to the panel discussion were concerns over risks for progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal demyelinating condition that can occur in patients receiving natalizumab (Tysabri) and other immunosuppressive medications and who are infected with JC virus.
However, in the only unanimous vote of the session, all 21 panelists voted Yes that Takeda had sufficiently accounted for the risk of PML to support approval; Takeda said that although no cases had occurred during phase III studies, the company would still conduct post-market research and include a warning in its packaging. The panel routinely supported its vote with praise for the risk mitigation strategy and post-market research.
Another vote concerned whether concomitantly administered immunosuppressants should be limited to a specific duration. The panel voted 19-1, with one abstention, against such a limit.
For each condition, the panel voted on whether benefits outweighed risks to support approval of the drug in patients who failed steroid, immunosuppressive, or TNF-alpha antagonists; immunosuppressants or TNF-alpha antagonists; or neither. The vote for ulcerative colitis favored treatment for all conditions, with 14 voting for the first option, seven voting for the second, and none voting for the third. Similarly for Crohn's disease, 14 favored the first option, six favored the second, and one panelist favored neither.
Regarding the vote for the ulcerative colitis indication, committee member Elaine Morrato, DrPH, of the Colorado School of Public Health in Aurora, voted for the least restrictive option, but noted that "the products should be effective, but I worry that a specific requirement for failure of immunosuppressant or anti-TNF would be overly burdensome when you're translating this into clinical practice," adding that she "would rather have those discussions left with the patient and the provider."
Those favoring the middle option preferred a bottom-up approach while waiting for additional data on which patient populations would be best served by the drug with the least risk.
The agency is not required to follow the advice of its advisory committees, though it often does.
