U.K. cost gatekeeper changes its tune on Entyvio for Crohn's

NICE's Carole Longson

Takeda has hit a few speedbumps lately, struggling with sagging sales and less-than-stellar profits after losing the patent for one of its top sellers. But the company is enjoying a bright point as the U.K. cost gatekeeper gave its thumbs-up to the company's inflammatory bowel disease drug Entyvio, dealing the company some good news as it looks to its gastrointestinal meds to revive its flagging fortunes.

The National Institute for Health and Care Excellence (NICE) did a U-turn on Entyvio (vedolizumab) for Crohn's, approving the drug to treat patients with a moderate or severe form of the disease who have not responded to therapy with TNF-alpha inhibitors, PharmaTimes reports. In December, the cost watchdog rejected the drug for Crohn's, saying that Entyvio didn't represent good value for patients in the U.K., even with a proposed discount through a patient access scheme.

But Takeda bounced back with new data, showing that Entyvio was more cost-effective than traditional therapy. "After considering further information, NICE is happy to be able to recommend vedolizumab as a treatment option for those with Crohn's disease. We hope the recommendation will benefit tens of thousands of people who live with this debilitating condition," said Carole Longson, Director of NICE Centre for Health Technology Evaluation, as quoted by PharmaTimes.

The NICE approval comes a few months after Takeda scored another positive recommendation from the U.K. cost gatekeeper for Entyvio. In March, NICE gave its thumbs-up to the drug to treat moderate to severely active ulcerative colitis as long as Takeda offered it at a discount through a patient access scheme. The drug provides a "welcome and effective alternative" to other products that treat the disease, Longson said at the time, as therapies such as corticosteroids often come with severe side effects. Entyvio, a 30-minute infusion, blocks the entry of white blood cells in the gut to reduce inflammation and symptoms including extreme fatigue and rectal bleeding.

Christophe Weber

Meanwhile, Takeda is working hard to jumpstart sales after losing the patent for its blockbuster diabetes drug, Actos. Under a plan laid out by new CEO Christophe Weber, the company said it would focus on its gastrointestinal and oncology meds and emerging markets to generate growth. Entyvio could play a key role in Takeda's turnaround, as the drug is forecast to hit $1 billion in peak sales by 2020.

But the company still faces some hurdles with the med. Entyvio is approved in the U.S. and EU as a second-line treatment for Crohn's and ulcerative colitis, and competes against tried-and-true products including AbbVie's ($ABBV) Humira, Amgen's ($AMGN) Enbrel and Johnson & Johnson's ($JNJ) Remicade and Simponi.

To that end, Takeda is also looking to its oncology portfolio and emerging markets to jumpstart its sales engine. Earlier this year, the company revealed positive data for its top oncology contender, ixazomib, a potential successor for its blockbuster Velcade. And Takeda is seeing progress in China and Russia, posting double-digit growth in the countries in 2014.

- read the PharmaTimes story

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