FDA to review Takeda's BLA resubmission for subcutaneous UC drug Entyvio after 2019 rejection
Takeda has refiled a biologics license application for its subcutaneous version of the blockbuster ulcerative colitis drug Entyvio following an FDA rejection in 2019, the company announced today.
The company expects a decision by the end of the year.
Entyvio was first approved in 2014 as an intravenous formulation to treat ulcerative colitis and Crohn’s disease, and Takeda last fall raised its peak sales estimates for the drug to $7.5 billion to $9 billion. However, the FDA issued a CRL to the company’s subcutaneous version in 2019 over issues related to the design and labeling of the device, Takeda said. The company specified that the CRL was not a result of safety or efficacy data, and was also unrelated to the IV formulation of the drug and conclusions from the VISIBLE 1 trial that tested Entyvio as a maintenance therapy given subcutaneously.
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