Takeda Announces One-Year Supply Disruption for 100-mcg Natpara Due to Manufacturing Delays

Compiled by Fan Dongdong

In an open letter addressed to the Hypoparathyroidism Association, as well as to the broader community of patients with hypoparathyroidism and healthcare professionals, Takeda announced that supplies of Natpara 100 mcg may be disrupted as early as this week, with the shortage expected to last approximately one year.

Tom Koutsavlis, Head of US Medical Affairs, and Cheryl Schwartz, Head of US Rare Diseases, wrote, “As part of Takeda’s rigorous quality and manufacturing processes, this supply delay has impacted the manufacturing and release of Natpara 100 mcg.” Takeda stated that it has now notified patients currently receiving Natpara treatment and their treating physicians through the company’s Special Use Program (SUP). Patients receiving SUP treatment with Natpara injection doses of 25 mcg, 50 mcg, and 75 mcg will not be affected by this supply shortage. Furthermore, staff from OnePath, the company’s rare disease support service, will ensure that existing patients maintain access to the 100 mcg dose.

Takeda Natpara Injection is a recombinant human protein that possesses the full-length 84-amino acid sequence of endogenous parathyroid hormone (PTH). It is currently approved in the United States as the sole adjunctive therapy for adult patients with chronic hypoparathyroidism whose condition cannot be adequately controlled with standard therapy (calcium and vitamin D) alone. Natpara can be used as an adjunct to calcium and vitamin D to help manage hypocalcemia in these patients.

In 2019, Takeda announced the recall of all Natpara injection dosage strengths in the U.S. market. The recall was due to potential safety concerns related to the possible injection of rubber particles into patients during the administration of Natpara. Although Takeda did not specify the exact cause of the subsequent supply disruption, the company stated that this shortage was unrelated to the previous recall incident. Takeda indicated that while “progress” had been made in addressing the initial cause of the U.S. recall, the issue had “not yet been fully resolved,” and the company continued to face “complex challenges” in making Natpara available to a broader patient population in the United States.

In addition to the recall, manufacturing delays have also pushed back the company’s previously anticipated timeline. Takeda expects that Natpara will “not be relaunched before March 31, 2022.” The company plans to inform the U.S. community of patients with chronic hypoparathyroidism about the situation via video conferences in the coming weeks.

Reference Source:

1.Supply of 100-mcg Natpara Interrupted for About 1 Year, Takeda Says

2.Takeda's rare disease med Natpara faces long road back to market as manufacturing issues multiply