Takeda Pharmaceutical Co. (4502)’s treatment for the two most common inflammatory bowel diseases won the backing of U.S. advisers to the Food and Drug Administration.
The benefits of the medicine, vedolizumab, outweigh the potential risk of the drug causing a deadly brain disease, the advisory panel voted today. The FDA, which isn’t bound by the panel’s recommendation, may decide whether to approve the drug for ulcerative colitis by Feb. 18 and Crohn’s disease in June.
Vedolizumab, which Osaka, Japan-based Takeda proposes calling Entyvio, works in a similar way to Biogen Idec Inc. (BIIB)’s Tysabri, which carries a boxed warning about the danger for the rare brain infection, known as progressive multifocal leukoencephalopathy. None of the more than 3,000 patients studied in Takeda clinical trials had the infection.
Panelists said the risk probably was small to nonexistent though they suggested the FDA require post-market surveillance.
Tysabri is approved to treat multiple sclerosis and Crohn’s disease. Takeda is seeking approval of vedolizumab for both uses in patients with moderate to severe forms of the diseases who haven’t responded or no longer respond to conventional therapy.
Standard treatments currently include corticosteroids, immunosuppressants or anti-TNF drugs like Johnson & Johnson (JNJ)’s Remicade and Simponi or AbbVie Inc. (ABBV)’s Humira. Those three branded drugs, which also treat rheumatoid arthritis, generated $19 billion in global sales last year, according to Bloomberg Industries.
The FDA deems Takeda’s application for the therapy in ulcerative colitis a priority, which means the agency will give it faster review than is standard because it considers the drug to be a significant enough improvement over current treatments.
Ulcerative colitis affects the large intestine while Crohn’s disease can cause inflammation anywhere in the gastrointestinal tract, though usually the condition is in the small bowel known as the ileum. Both can cause discomfort, pain and diarrhea and each affect about 700,000 people in the U.S., according to Takeda.
Thirteen panel members today voted to approve vedolizumab as Takeda requested for ulcerative colitis; 14 voted for the same in Crohn’s disease. Eight panel members recommended ulcerative colitis patients try more than steroids before vedolizumab; six recommended the same limitation in Crohn’s.
Clinical trials showed vedolizumab is effective in ulcerative colitis and one trial found the injection works against Crohn’s disease while another study failed to replicate effectiveness in patients who were resistant to other treatments, according to a Dec. 5 FDA staff report.
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