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FDA panel backs Takeda's inflammatory bowel disease drug

Vedolizumab on course for US approval to treat Crohn’s disease and ulcerative colitis

Takeda pharma buildingTakeda's Millennium Pharmaceuticals unit took a step closer to US approval for one of its top pipeline prospects - vedolizumab for inflammatory bowel disease (IBD) - after a Food and Drug Administration (FDA) panel gave its blessing to the drug.

The agency's Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted 20 to 1 in favour of approving vedolizumab to treat Crohn's disease (CD) and unanimously for ulcerative colitis (UC).

Vedolizumab is a monoclonal antibody targeting the alpha4beta7 integrin on white blood cells, which is thought to work by selectively dampening down the inflammatory response in in the gastrointestinal tract, leaving other areas of the body largely unaffected.

That selective action is designed to make treatment safer than with other biologic therapies for CD and UC, including TNF blockers - such as AbbVie's Humira (adalimumab) and Johnson & Johnson/Merck/Mitsubishi's Remicade (infliximab), which have a systemic immune-suppressing effect that can leave patients vulnerable to serious infections.

Much of the discussion in the panel meeting focused on the potential risks of progressive multifocal leukoencephalopathy (PML), a rare side effect seen with Biogen Idec's multiple sclerosis treatment Tysabri (natalizumab) which is considered to have a similar mechanism to vedolizumab.

On balance the committee concluded that the benefits of the drug outweighed its risks, and it was acceptable to leave risk considerations in the hands of doctors and their patients.

Within the voting, 13 committee members said vedolizumab should be reserved for use in UC patients who failed treatment with steroids, immunosuppressants or TNF inhibitors, while eight said the drug should be used after immunosuppressants or TNF blockers. It should not be used in patients who have only been treated with steroids.

Similarly, for CD a majority of panellists (14) said the drug should be used in patients whose disease is not controlled by steroids, immunosuppressants or TNF blockers, while six indicated it should be used after immunosuppressants or TNF blockers.

The TNF blockers remain the mainstay of biologic therapy for CD and to a lesser extent UC, but are gaining ground thanks as subcutaneous formulations of Humira and Janssen/Merck/Mitsubishi Tanabe's Simponi (golimumab) start to replace intravenous infusions such as Remicade. 

Vedolizumab will initially be used second-line after TNF blockers or immunosuppressants but with long-term experience could potentially be used after steroids alone as an alternative to TNF blockers, as there is preliminary evidence it may improve remission rates in UC.

Overall, the CD sector is expected to increase from a value of around $3.8bn in the seven-largest pharma markets to $5.6bn in 2021, while UC will increase from $1.7bn in 2010 to $3bn by 2020, according to data from Decision Resources.

The FDA is scheduled to deliver its verdict on vedolizumab in UC by February 18, 2014, and in CD by June that year, although it may do so sooner.

Article by
Phil Taylor

11th December 2013

From: Sales



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