IMPORTANT INFORMATION REGARDING CLOSURE OF THE NATPARA^® SPECIAL USE PROGRAM

The purpose of this communication is to inform you of the upcoming closure of the NATPARA^® Special Use Program (SUP). Following global manufacturing discontinuation of NATPARA at the end of December 2024 as previously communicated in October 2022, September and December 2024, and in alignment with the U.S. Food and Drug Administration (FDA), the SUP will be closing as of December 31, 2025. This means that no further NATPARA shipments will be sent to SUP patients after this calendar year.

As you may recall, the SUP was initiated in agreement with the FDA on September 24, 2019 as a temporary program to allow patients at risk of extreme health consequences resulting from the NATPARA recall to have access to NATPARA. The recall was initiated on September 5, 2019 due to the potential for rubber particulates from the rubber septum of the NATPARA cartridge to enter the cartridge. Despite subsequent in-depth research and analysis, Takeda determined that it could not implement an approvable solution to the rubber particle issue. Consequently, NATPARA remains a product recalled by the FDA and cannot be commercialized in the U.S.

The main reason the FDA supported Takeda’s efforts to make the recalled product available in the U.S. through the SUP was the unavailability at that time of an alternate approved parathyroid hormone for the treatment of patients with hypoparathyroidism. In August 2024, the FDA approved Yorvipath (palopegteriparatide) injection for subcutaneous use in adults with hypoparathyroidism (https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-drug-hypoparathyroidism-rare-disorder).

If your patient(s) is/are still enrolled in the SUP, it is very important to meet as soon as possible with your patient(s) to allow sufficient time to develop alternate treatment plans, including, if appropriate for your patient(s), potential transition to the recently FDA-approved treatment for adult patients with hypoparathyroidism. The decision as to whether this treatment is appropriate for your patient(s) entails an HCP-patient discussion and eventual decision. While Takeda cannot recommend nor endorse this treatment due to regulatory considerations, we are committed to ensuring the relevant information is easily accessible to support informed decision-making for the benefit of patients.

This communication is not intended as a complete description of the benefits and risks related to the use of NATPARA. Please visit www.natpara.com for the full Prescribing Information and Medication Guide.