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

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by Forest Ray PhD |

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An interruption in the supply of Natpara 100 micrograms (mcg) could begin as early as this week and last for about one year, Takeda Pharmaceuticals announced in an open letter to the Hypoparathyroidism Association and to the broader hypoparathyroidism patient and healthcare community.

“As part of our rigorous quality and manufacturing processes, we have experienced a delay that’s affected the manufacturing and release of NATPARA 100-mcg,” wrote Tom Koutsavlis, the company’s head of U.S. medical affairs, and Cheryl Schwartz, head of the U.S. rare disease business unit.

Takeda has notified patients currently receiving Natpara through the company’s special use program (SUP), as well as their doctors. SUP-enrolled individuals using the injection treatment at its 25 mcg, 50 mcg, and 75 mcg doses will not be affected. The company will inform and update patients through their OnePath Patient Support Managers.

While Takeda did not specify what is causing the interruption, except to say that it affects manufacturing, it stated that the issue is unrelated to the U.S. Natpara recall in 2019. That recall was due to the risk of small rubber fragments detaching from the packaging and contaminating the medication. Takeda continues to work with U.S. authorities to resolve this matter.

“While we have made progress on the original issue that led to the U.S. recall,” the company stated, “we continue to face complex challenges in bringing NATPARA back to the broader patient community in the U.S.”

The manufacturing delay on top of the recall has set back company timelines, and Takeda said that does not expect “a return to market before March 31, 2022.”

The company plans to address the U.S. chronic hypoparathyroidism patient community via WebEx video conference in the coming weeks. Updates related to Natpara will also be posted to this company webpage.

Natpara is a synthetic form of the parathyroid hormone, designed to mimic that hormone’s effects. The U.S. Food and Drug Administration approved the use of Natpara, given with calcium and vitamin D, for the treatment of hypoparathyroidism in 2015.

“We recognize that this update may be difficult for those who have been eagerly awaiting information about our anticipated timelines for bringing NATPARA back,” Takeda wrote. “We are also disappointed that there is not better news to share with you.”