The FDA sent Takeda a questioning letter in response to the company's biologics license application concerning the subcutaneous formulation of Entyvio, a maintenance therapy for ulcerative colitis.
What you should know:
1. Takeda sought approval for an investigational subcutaneous formulation of Entyvio.
2. The FDA posed several questions that Takeda said were "unrelated to the clinical data and conclusions from the pivotal trial supporting the [application]."
3. The FDA approved Entyvio as an intravenously delivered drug in 2014. Since then, the drug has been used in more than 150,000 patients in the U.S. Takeda believes the subcutaneous formulation has benefits for patients with UC and will continue to seek approval.
4. To earn the approval, Takeda said it will work closely with the FDA.