Takeda has received a Complete Response Letter from the U.S. Food and Drug Administration in response to the Prior Approval Supplement for NATPARA 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 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, the company continue to work on the separate supply challenges surrounding protein particle formation that the company 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.