OSAKA, Japan, and CAMBRIDGE, Massachusetts, March 22, 2022 – Takeda (TSE:4502/NYSE:TAK) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. issued a statement today that Takeda has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the Prior Approval Supplement (PAS) for NATPARA (parathyroid hormone) for Injection, stating that the PAS cannot be approved in its present form. The PAS was submitted in August 2021 to address the potential for rubber particulate formation that led to a local U.S. recall in September 2019. Takeda is evaluating the details of the CRL to determine next steps. In the meantime, NATPARA’s commercial return in the U.S. is indefinitely delayed.
Takeda intends to provide patients who are enrolled in the NATPARA Special Use Program (SUP) with continued access to therapy free of charge, in accordance with regulatory oversight and under the discretion of the FDA, until a commercial product is available.
With the goal of limiting supply interruption for SUP patients, we continue to work on the separate supply challenges surrounding protein particle formation that we have described over the past year. Those challenges are unrelated to the PAS and the recall. It is important to underscore that all product released for patient use continues to meet Takeda’s quality standards and the safety profile of NATPARA has not changed.
Takeda understands and has tremendous empathy for how much the community has been impacted without NATPARA. We will continue to support this community, and more information can be found in the Takeda U.S. Newsroom at https://www.takeda.com/en-us/newsroom/natpara-updates/.
Takeda does not expect a material impact on the full-year financial forecast for the year ending March 31, 2022, as a result of receiving the CRL and the supply challenges.
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.
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