Takeda files IBD drug vedolizumab in Europe

Takeda has filed for approval in Europe of inflammatory bowel disease (IBD) drug vedolizumab, one of its key pipeline drugs.

Vedolizumab is a gut-selective monoclonal antibody that targets the alpha4beta7 integrin on leukocytes thought to be involved in the development of ulcerative colitis (UC) and Crohn's disease (CD), and appears to dampen down inflammation in the gut without affecting immune system in the entire body.

The drug is being billed as a potentially safer alternative to tumour necrosis factor (TNF) blockers such as Johnson & Johnson/Merck/Mitsubishi's Remicade (infliximab) and AbbVie's Humira (adalimumab), which have a systemic immune-suppressing effect which can lead to serious infections, including tuberculosis.

The filing is based on four phase III GEMINI trials - said to be the largest IBD study programme ever carried out with around 3,000 patients - which showed vedolizumab met the objectives of inducing a clinical response and maintaining remission in Crohn's and UC patients, without any apparent increase in serious infections.

"Vedolizumab has clinical promise as a potential treatment option for people with moderate to severely active Crohn's and UC," said Paul Rutgeerts, of the Catholic University of Leuven in Belgium.

"While there is no known cure, there is a need for new CD and UC treatment options, in an effort to provide patients with additional choices for managing their disease, reducing symptoms and achieving remission," he added.

Vedolizumab is expected to be used initially as a second-line therapy after TNF blockers in IBD, which affects nearly 4 million people worldwide, but is considered an key growth driver for Takeda as it weathers the loss in sales caused by the onset of generic competition to its diabetes blockbuster Actos (pioglitazone).

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

Growth for vedolizumab and other new entrants such as Johnson & Johnson's interleukin-23 inhibitor Stelara (ustekinumab) and GlaxoSmithKline/ChemoCentryx' vercirnon in Crohn's - and Pfizer's JAK inhibitor tofacitinib in UC - will outpace a decline in sales of older drugs from generics erosion and declining use, it says.

Sales of the two biggest IBD products - Remicade and Humira - will peak at $3.7bn a year in 2016, says Decision Resources, and sales will begin to decline in 2017 due in part to the increasing uptake of biosimilar versions.