Takeda to Discontinue Manufacturing Natpara for Patients with Hypoparathyroidism at End of 2024

Takeda said it will discontinue manufacturing the parathyroid hormone Natpara for injection globally at the end of 2024 due to unresolved supply issues and manufacturing problems. As a result, Takeda will not re-commercialize Natpara in the U.S. and will discontinue manufacturing Natpara globally.

Until the end of 2024, Takeda says its priority is to maintain treatment continuity for the 3,000 or so patients who are currently receiving Natpara, subject to available supply. This includes those enrolled in the U.S. Special Use Program and all patients receiving it in Europe, where it is marketed as Natpar, and other regions around the world. Beyond 2024, Takeda intends to supply available doses until inventory is depleted or expired. Takeda will provide updates before the manufacturing end date and ahead of any potential supply interruptions.

Hypoparathyroidism is a rare endocrine disorder in which the parathyroid glands in the neck do not produce enough parathyroid hormone (PTH). Common signs and symptoms include abdominal pain, brittle nails, cataracts, dry hair and skin, muscle cramps, tetany, pain in the face, legs, and feet, seizures, tingling sensation, and weakened tooth enamel in children. The goal of treatment is to restore the calcium and mineral balance in the body.

Takeda acquired Natpara through its acquisition of Shire in early 2019. In September 2019, it was recalled in the United States due to rubber particulates originating from the rubber septum of the injection cartridge. The problem of particulates was never solved.

Takeda said it has continued to communicate updates about persistent supply challenges surrounding protein particle formation that are unique and specific to Natpara. Over the past several years, the company said it has explored numerous ways to address the protein particle issue to improve sustainable supply. Some of the specific steps included focused root cause analysis, computational modeling, evaluation and implementation of manufacturing process changes and reformulation research and development. Separately, after evaluation of the U.S. Complete Response Letter received earlier this year, Takeda determined it cannot implement a solution to the rubber particle formation issue, which led to the U.S. recall of Natpara in 2019 and made the decision to take it off the market.

Author: Rare Daily Staff