FDA rejects new drug application from Takeda for budesonide for EoE
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Takeda Pharmaceutical Company Limited announced it received an FDA complete response letter in response to its new drug application for TAK-721 for the treatment of eosinophilic esophagitis, according to a release.
Many gastroenterologists were looking forward to TAK-721 moving forward to FDA approval and now disappointed they still need to wait for an FDA approved therapy for EoE.
“I am looking forward to an FDA-approved medication for the treatment of EoE to get our patients safe and effective medications that are covered,” Scott Gabbard, MD, a gastroenterologist at the Digestive Disease & Surgery Institute at Cleveland Clinic, told Healio.
Gabbard was involved in the clinical trial.
According to the press release, in the complete response letter the FDA noted it completed the review of the TAK-721 (budesonide oral suspension) new drug application, and said the treatment could not be approved in its present form.
The FDA suggested Takeda perform an additional clinical study to resolve the FDA feedback.
“We are disappointed by the outcome of the FDA’s review of TAK-721, and that EoE patients will still be without a treatment option that the FDA has approved as safe and effective,” Ramona Sequeira, president of Takeda’s U.S. business unit and global portfolio commercialization, said in the release. “Takeda is assessing the details of the [complete response letter] and evaluating a regulatory path forward.”
Editor’s Note: On Jan. 13, 2022, this article was updated to include original comment from Scott Gabbard, MD.
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Takeda receives complete response letter from the U.S. FDA for TAK-721. https://www.takeda.com/newsroom/newsreleases/2021/takeda-receives-complete-response-letter-from-the-us-fda-for-tak-721/. Published Dec. 21, 2021. Accessed Jan. 04, 2022.
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