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FDA grants priority review to Takeda's colitis drug

Accelerates review time for vedolizumab

Takeda pharma buildingOne of Takeda's top pipeline prospects - vedolizumab for ulcerative colitis (UC) - has been given a priority review by the US Food and Drug Administration (FDA).

The announcement continues a run of positive news for vedolizumab, which was filed for approval in the US in June and in the EU in March for the treatment of adults with moderately to severely active Crohn's disease (CD) or UC and is in late-stage clinical testing in Japan.

The drug - which Takeda acquired via its takeover of Millennium - has been tipped as a potential blockbuster that could restore growth at the company in the wake of the loss of patent protection on diabetes drug Actos (pioglitazone).

The new FDA status for the drug's use in UC cuts the target review time for vedolizumab from 12 to eight months and is awarded to compounds that provide a significant improvement in safety or effectiveness. The CD indication will be reviewed under the agency's standard timeframe as there are already multiple effective treatments available for this condition.

Vedolizumab was found to be particularly effective for UC in clinical trials reported earlier this year, raising hope for patients living with the disorder, who number more than 600,000 in the US alone.

The drug achieved a clinical response in 47 per cent of UC patients after six weeks' treatment, compared to 26 per cent of the placebo arm, while remission rates at one year were 42 to 45 per cent - depending on dosing - compared to 16 per cent with placebo.

Vedolizumab is a gut-selective monoclonal antibody that targets the alpha4beta7 integrin on leukocytes and is thought to reduce inflammation in the gut without affecting immune system in rest of the body.

The UC market is valued at around $2bn a year - much smaller than the CD market which sees significant sales of tumour necrosis factor (TNF) blockers such as Johnson & Johnson/ Merck/ Mitsubishi's Remicade (infliximab) and AbbVie's Humira (adalimumab) - and is expected to grow 50 per cent in the next few years.

The market is set to undergo a major shake-up with the recent approval for UC of Humira as well as Johnson & Johnson's Simponi (golimumab), a TNF inhibitor that is also used to treat rheumatoid arthritis and ankylosing spondylitis. Meanwhile, Pfizer is testing its JAK inhibitor for arthritis - Xeljanz (tofacitinib) - for UC.

Article by
Phil Taylor

6th September 2013

From: Sales

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