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  • Takeda receives USFDA...

Takeda receives USFDA Complete Response Letter for Budesonide Oral Suspension

Ruchika SharmaWritten by Ruchika Sharma Published On 2021-12-22T11:30:24+05:30  |  Updated On 16 Oct 2023 2:46 PM IST
Takeda receives USFDA Complete Response Letter for Budesonide Oral Suspension
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Osaka: Takeda Pharmaceutical Company Limited has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to its New Drug Application (NDA) for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.

The CRL indicates the FDA has completed its review of the TAK-721 NDA and determined that it cannot be approved in its present form. In addition, the FDA recommended an additional clinical study in order to help resolve 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," said Ramona Sequeira, President, U.S. Business Unit and Global Portfolio Commercialization, Takeda. "Takeda is assessing the details of the CRL and evaluating a regulatory path forward."

TAK-721 (budesonide oral suspension) is an oral viscous formulation of budesonide, formulated as an investigational treatment for eosinophilic esophagitis. It entered the Takeda pipeline through the company's acquisition of Shire.

Read also: Takeda Livtencity gets USFDA nod for treatment of post-transplant cytomegalovirus infection

Takeda Pharmaceutical Company Limited is a global, R&D-driven biopharmaceutical company headquartered in Japan. The company focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI).

Read also: Takeda's dengue vaccine efficacious, decreases hospitalization in adolescents

takedatakeda pharmausfdatak-721budesonide oral suspensioneosinophilic esophagitisesophagus
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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