Takeda Pharmaceutical Co.’s drug vedolizumab faces U.S. concern that its potential risk for a deadly brain infection outweighs the benefits in treating the two most common inflammatory bowel diseases.
The experimental medicine has the potential to cause a rare virus that attacks the white matter of the brain, Food and Drug Administration staff members wrote in a report today ahead of a Dec. 9 meeting of agency advisers to discuss the therapy. The FDA may decide whether to approve vedolizumab for ulcerative colitis by Feb. 18 and Crohn’s disease in June.
Patients in Takeda’s clinical trials on the drug didn’t experience the infection, known as progressive multifocal leukoencephalopathy, FDA workers said. The drug works in a similar way as natalizumab, or Biogen Idec Inc.’s Tysabri, which carries a boxed warning about the danger. The FDA report questioned whether Osaka, Japan-based Takeda’s safety data are sufficient to prove, as the company claims, that the risk is lower in vedolizumab.
“Thus, it will be difficult to infer that one drug has a more desirable risk profile than the other; any comparisons of risk between vedolizumab and natalizumab will be crude and should be interpreted with caution,” the FDA staff wrote.
Tysabri is approved to treat multiple sclerosis and Crohn’s disease.
Clinical trials showed vedolizumab is effective in ulcerative colitis and one trial found the drug works against Crohn’s disease while another study failed to replicate effectiveness in patients who were resistant to other treatments, according to the FDA report.
The FDA deems Takeda’s application for the therapy in ulcerative colitis a priority, which means the agency considers the drug to be a significant enough improvement over current treatments to gain faster review than is standard. Other drugs for the condition include Johnson & Johnson’s Remicade and Simponi and AbbVie Inc.’s Humira. Those three drugs, which also treat rheumatoid arthritis, generated $19 billion in global sales last year, according to Bloomberg Industries.
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.
Takeda has proposed calling the injection Entyvio. The company is seeking approval for both uses in patients with moderate to severe forms of the diseases who haven’t responded or no longer respond to conventional therapy, such as corticosteroids, or anti-TNF drugs like Remicade and Humira, which also treat Crohn’s disease.
The FDA said the agency is considering restricting vedolizumab’s use in combination with immunosuppressants to lower the risk of infection, same as Tysabri. Immunosuppressants are considered typical treatment for the diseases.