The US Food and Drug Administration (FDA) has accepted Takeda’s biologics license application (BLA) for the company’s investigational subcutaneous administration of Entyvio (vedolizumab) for the treatment of Crohn’s disease.

The BLA, which is for maintenance therapy of moderate to severe active forms of the disease after induction therapy with IV vedolizumab, will now be reviewed by the FDA alongside a separate BLA submitted by Takeda for the same formulation indicated for ulcerative colitis treatment.

Dr Vijay Yajnik, vice president and head of US Medical for Gastroenterology at Takeda said in a statement: “With two applications for a subcutaneous option of Entyvio now under FDA review, we remain firm in our commitment to the inflammatory bowel disease community—adults with ulcerative colitis or Crohn’s disease—and the healthcare professionals actively managing their care.”

Takeda submitted the most recent BLA with data from a Phase III clinical trial demonstrating that Entyvio led to a significant decrease in Chron’s Disease Activity Index compared to a placebo after six weeks of treatment.

The 108mg subcutaneous formulation of Entyvio was administered every two weeks in patients with moderately to severely active Crohn’s disease previously treated with two doses of vedolizumab intravenous (IV) therapy. A total of 409 patients were involved in the study who did not previously respond to alternative therapies including corticosteroids, immunomodulators, or anti-tumour necrosis factor (TNF) therapies – including AbbVie’s Humira.

Though Entyvio is a widely approved therapy worldwide, it is not yet approved for subcutaneous formulation in the US.

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In April 2023, Takeda resubmitted a BLA for the subcutaneous Entyvio for ulcerative colitis treatment after a previous FDA rejection in 2019.

The drug works by blocking the interaction between T cells and the endothelial cells of the gastrointestinal tract. This prevents T-lymphocyte migration into the gut and reduces inflammation.

GlobalData forecasts global sales of Entyvio to reach $7.9bn by 2029.

The Crohn’s disease market, dominated by AbbVie’s blockbuster TNF-blocker Humira (adalimumab), has seen a significant shift with the proliferation of biosimilars.

GlobalData’s immunology senior analyst Adeleke Badejo comments: “The biologic-exposed market targeted by Janssen and Takeda is the strategy being implemented by most companies to displace AbbVie; a rush to market to establish a significant market share as opposed to providing the next generation replacement of adalimumab.”