Takeda’s Millennium Pharmaceuticals unit has been given a green light in the US for Entyvio, a treatment for inflammatory bowel disease (IBD) patients who have not responded to current therapies.
The FDA approved Entyvio (vedolizumab) to treat adults with moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD) who cannot get adequate relief from one or more current standard treatments, which include corticosteroids, immunomodulators, or tumour necrosis factor (TNF) blockers.
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.
Its mechanism is designed to make it safer than other therapies for IBD, notably the TNF blockers such as AbbVie’s Humira (adalimumab) and Johnson & Johnson/Merck/Mitsubishi’s Remicade (infliximab) that can dampen down systemic immunity and can be associated with opportunistic infections.
It won a ringing endorsement from an FDA advisory panel last December, on the back of four phase III trials which showed it was effective in achieving and maintaining corticosteroid-free clinical remission compared to placebo.
The FDA’s Amy Egan commented in a statement that Entyvio “provides an important new treatment option for patients who have had an inadequate response to conventional therapy”.
The FDA has approved Takeda’s drug with an acknowledgment of a potential risk of progressive multifocal leukoencephalopathy (PML), a rare side effect also seen with Biogen Idec’s integrin blocker Tysabri (natalizumab) for multiple sclerosis, but said this would be monitored via post-marketing surveillance and adverse event reporting.
Entyvio is also under regulatory review in Europe – getting a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in March – and is tipped as a blockbuster by analysts at Deutsche Bank who have suggested annual sales of $1bn are feasible for the drug at peak.
Consensus forecasts are a somewhat lower at around $500m by 2018, and a lot will depend on now vedolizumab can be positioned in the market, given that it requires an intravenous infusion while some of its TNF blocker rivals can be given subcutaneously.
Takeda is working on a subcutaneous formulation of vedolizumab but this is unlikely to reach the market before fiscal 2017-2018, according to the company’s latest pipeline update.