(Adds vote details, background, panel discussion details)
By Bill Berkrot
Dec 9 An advisory panel of medical experts on
Monday voted to recommend that U.S. health regulators approve an
experimental drug for ulcerative colitis and Crohn's disease
developed by Takeda Pharmaceutical Co.
The panel voted by wide margins that the benefits outweigh
the risks of the biotech drug, vedolizumab, and advised the Food
and Drug Administration to approve it for both ulcerative
colitis and Crohn's disease in patients who have not been helped
by prior therapies.
The FDA typically follows the recommendations of its expert
advisory panels, but is not obligated to do so.
The panel was impressed with the available data in treating
ulcerative colitis and voted 21-0 to back the drug.
However, eight of the panelists voted that it should not be
recommended for use after steroids fail, saying there where
other options. The other 13 recommended the Takeda drug for use
after immune suppression drugs, anti-TNF biologic medicines or
For Crohn's disease, 20 voted to support approval and one
voted to reject the drug. Of the 20, six felt vedolizumab should
not follow steroids, but backed its use after failure of
immunosuppressants and/or biologics.
Much of the panel discussion on Monday centered around how
vedolizumab could pose a risk of a potentially fatal brain
infection called progressive multifocal leukoencephalopathy
(PML) and how the drugmaker and doctors might deal with it.
No patient taking part in clinical trials of the drug,
which would be sold under the proposed brand name Entyvio,
experienced PML. The concerns were raised because the Takeda
drug works in a similar manner as another medicine used to treat
multiple sclerosis that has been associated with PML infection.
They voted 21-0 that Takeda had sufficiently characterized
the potential PML risk to support vedolizumab approval for both
conditions. However, many of the panelists said post-marketing
monitoring and risk management strategies should be required to
watch for any safety issues that might crop up once the drug is
Crohn's disease and ulcerative colitis are common forms of
inflammatory bowel disease, and can cause discomfort, diarrhea,
bleeding and other serious problems, often requiring surgery.
Several patients and doctors testified at the hearing about
just how detrimental to quality of life those diseases are, and
stressed the need for new treatments for thousands of patients.
Takeda earlier this year filed for marketing approval of
Entyvio in the United States and Europe. The drug is a
monoclonal antibody meant to control inflammation by blocking a
protein called alpha4beta7 integrin.
(Reporting by Bill Berkrot; Editing by Steve Orlofsky and Andre