Dec 5 An experimental drug for ulcerative
colitis and Crohn's disease from Takeda Pharmaceutical Co
could pose risk of a potentially fatal brain infection
called PML even though the problem has not been seen in clinical
trials, staff members of the U.S. Food and Drug Administration
said on Thursday.
Documents about the monoclonal antibody, called Entyvio,
were released by the FDA staff ahead of a planned meeting on
Monday among a panel of outside medical experts who will review
the safety and effectiveness of the medicine and make
recommendations to the FDA.
Japanese drugmaker Takeda earlier this year filed for
marketing approval of Entyvio, whose chemical name is
vedolizumab, in the United States and Europe.
Some 3,326 patients have received one or more infusions of
the medicine in its various clinical trials, with no cases of
the brain infection seen, the FDA staff said in a lengthy review
document meant to flag potential concerns to the panel of
outside medical experts.
A larger database of safety information would better enable
reviewers to assess the PML risk, the document said.
The document expressed concern that PML, formally known as
progressive multifocal leukoencephalopathy, has been seen in a
drug that works through a similar mechanism: Biogen Idec Inc's
Tysabri treatment for multiple sclerosis.
The FDA staff noted, however, that Tysabri's risk of causing
PML may be partly due to the fact it is often taken over long
periods and among patients that have been previously treated
with drugs that suppress the immune system.
There have been 12 deaths in patients who have received
Entyvio, none of which have been linked to the injectable drug,
according to the briefing document.
The FDA staff questioned whether the benefit of Entyvio
outweighs its risks, especially the risk of PML, and whether
risk management strategies to prevent PML may be needed if the
drug is approved.
Crohn's disease and ulcerative colitis are common forms of
inflammatory bowel disease, and can cause discomfort, diarrhea,
bleeding and other problems.
Entyvio is a monoclonal antibody meant to control
inflammation by blocking a receptor, or protein, called