Patients taking Takeda’s Entyvio for Crohn’s disease will now have the option of a subcutaneous version.
Takeda announced the label expansion on Friday, several months after winning a first approval for the subcutaneous formulation in ulcerative colitis. Entyvio, or vedolizumab, was originally approved as an intravenous drug in 2014 and administered via a roughly 30-minute-long infusion.
The new formulation is taken as a maintenance therapy following induction with IV Entyvio. It’s a single-dose, prefilled pen, to be self-administered “at home or on the go,” Takeda’s US gastroenterology business unit head Brandon Monk said in a news release.
“Some patients may prefer an SC administration as it allows flexibility for self-administration in a home setting, while others may favor IV administration due to more regular touchpoints with a health care provider,” a Takeda spokesperson told Endpoints News. “By meeting patient needs and preferences, we hope to reduce the impact that a chronic condition can have on the day-to-day life of a patient.”
The list price is about $6,240 per 28 days, or two pens.
Takeda’s first attempt at a subcutaneous approval for Entyvio fell short in December 2019 over concerns “related to the design and labeling” of the device. The FDA’s questions had nothing to do with clinical safety or efficacy data, the company said at the time. Those concerns were cleared up in a resubmission last year, at which point the formulation had already been approved in Europe, Canada and Australia.
The Crohn’s disease market is packed with competitors, including J&J’s Stelara and AbbVie’s Humira and Skyrizi, which are all available as subcutaneous injections. AbbVie’s Rinvoq was approved last year as a once-daily pill to treat Crohn’s disease patients who’ve failed on at least one TNF blocker.