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Takeda’s subcutaneous Entyvio formulation faces FDA rejection

Was seeking approval in moderate-to-severe ulcerative colitis

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A subcutaneous formulation of Takeda’s key growth product Entyvio has been rejected by the FDA, as a maintenance treatment for adults with moderate-to-severe ulcerative colitis (UC). 

The anti-integrin antibody Entyvio (vedolizumab) is an important growth products for Takeda as it faces loss of patent protection in the US for its blockbuster multiple myeloma drug Velcade (bortezomib).

The intravenous indication is already approved for use in adults patients with moderate-to-severe active UC, who have had an inadequate response, lost response to or were intolerant to standard treatments.

It also indicated for use in adult patients with moderate-to-severe active Crohn’s Disease who have similarly had inadequate responses to standard treatments.

Takeda showcased a study of the intravenous formulation of Entyvio earlier this year, which positioned it head-to-head with AbbVie’s ageing immunology blockbuster Humira (adalimumab).

The VARSITY study pitted the two against each other in patients with more severe presentations of UC, and demonstrated that 31.3% of patients treated with Entyvio given every two months after a lead-in period, were in remission from the inflammatory bowel disease after a year.

In comparison, 22.5% of patients who received Humira every other week reached remission in the same time period.

Takeda were hush on the details of the complete response letter, but have said that the “FDA posed questions unrelated to clinical data and conclusions from the pivotal trial supporting the biologics license application”.

“At Takeda, we know how important it is to provide physicians and patients with choices, and we continue to drive innovation and development to meet their needs,” said Asit Parikh, head of Takeda’s Gastroenterology Therapeutic Area Unit.

“We’re committed to the development of the subcutaneous formulation of Entyvio, and look forward to working closely with the FDA to determine next steps,” he added.

Takeda is also betting on pipeline products from its £46bn takeover of Irish biotech Shire to offset loss from patent challenges, although home-grown products like Entyvio are important too as the Japanese pharma needs to deliver sales growth of its own drugs ahead of the integration of the two businesses.

Article by
Lucy Parsons

23rd December 2019

From: Regulatory



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