FDA
10th December 2013

FDA Supports vedolizumab for Ulcerative Colitis, Crohn’s Disease

Yesterday, a joint meeting of the FDA’s Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted in favor of recommending vedolizumab, an investigational humanized monoclonal antibody by Takeda Pharmaceuticals, for the treatment of Crohn’s disease and ulcerative colitis.

FDA Supports vedolizumab for Ulcerative Colitis, Crohn’s Disease

Yesterday, a joint meeting of the FDA’s Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted in favor of recommending vedolizumab, an investigational humanized monoclonal antibody by Takeda Pharmaceuticals, for the treatment of Crohn’s disease and ulcerative colitis.

Crohn’s disease and ulcerative colitis are both inflammatory bowel diseases (IBDs).

Crohn’s disease causes inflammation of the lining of your digestive tract, which can lead to abdominal pain, severe diarrhea and even malnutrition.

Ulcerative colitis usually affects only the innermost lining of your large intestine (colon) and rectum. It occurs only through continuous stretches of your colon, unlike Crohn’s disease, which occurs anywhere in the digestive tract and often spreads deeply into the affected tissues. Ulcerative colitis is a chronic condition. Thus, symptoms usually develop over time, rather than suddenly. 

These diseases can be both painful and debilitating, and sometimes, may lead to life-threatening complications. Inflammation caused by these bowel diseases can involve different areas of the digestive tract in different people and can be long-lasting.

A key issue in the discussion was the risk for progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal brain virus.

No patients who took part in clinical trials of vedolizumab developed PML; however, questions were raised because of the possible link to the virus.

“I think having some good data on PML will once and for all put this question to rest on this very interesting molecule,” Kenneth Koch, MD, chief of gastroenterology at Wake Forest University Baptist Medical Center, said. 

Despite those concerns, the panel voted that the benefits of vedolizumab outweighed the potential risks for patients suffering from Crohn’s disease/ulcerative colitis. Thirteen joint committee members voted to recommend approval for the proposed ulcerative colitis population that failed steroids or immunosuppressants or tumor necrosis factor-alpha (TNF-a) antagonists, while eight members voted to recommend approval for patients that have failed immunosuppressants or TNF-a antagonists, which would result in the indicated population not including patients that failed steroids only.

Furthermore, 14 panel members voted the benefits also outweighed potential risks for patients with Chron’s disease who have failed steroids or immunosuppressants or TNF-a-antagonists to 6 who voted for the option that would not include patients who failed steroids only.

“I think this patient population is slightly difficult … we have very few options,” Gagan Sood, MD, of the department of medicine and surgery at Baylor College of Medicine, said of his vote with the majority.

Myla Goldman, MD, MSc, of the department of neurology at University of Virginia Health Systems added, “I felt that this agent should be available to a broader population and decisions about risk balance should be left in the hands of the physician and patient.”

The joint committee also made clear its support for the importance of post-market risk mitigation strategies beyond labeling, to ensure the product’s benefits outweigh its risks.

While there’s currently no known cure for Crohn’s disease or ulcerative colitis, therapies are available that can greatly reduce the signs and symptoms of these diseases and even bring about long-term remission. With treatment, many people with these diseases are able to function well.

The final FDA decision on whether to approve the treatment for use among ulcerative colitis patients and Crohn’s disease patients is expected by February and June of 2014, respectively. The FDA is not required to follow the panel’s recommendation but usually does so. 

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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