FDA Issues CRL for Natpara for Hypoparathyroidism


The CRL delays the commercial return in the United States, Takeda didn’t release any information about the reason for the CRL.

The FDA has issued a complete response letter (CRL) in response to the Takeda’s prior approval supplement for Natpara (parathyroid hormone). Takeda had submitted its supplement in August 2021 to address the potential for rubber particulates in the product that led to the recall in September 2019. At the time, Takeda had recalled all doses of Natpara.

Natpara, a recombinant human protein, is a parathyroid hormone used to control low blood calcium in people with low parathyroid hormone blood levels. It is indicated for patients with chronic hypoparathyroidism who cannot be adequately controlled with standard therapy alone (calcium and vitamin D).

Natpara has not been commercially available since the recall, although some patients received the therapy free of charge through a special use program under the guidance of the FDA. The CRL delays the commercial return in the United States, the company said.

As part of its prior approval supplement, Takeda proposed device component changes that included a new septum and new needle. The 2019 recall was because of rubber particulates that originated from the rubber septum of the Natpara cartridge. During the 14-day treatment period with Natpara, the septum is punctured by a needle each day to obtain the daily dosage. When the septum is repeatedly punctured, it is possible that small rubber fragments may detach into the cartridge.

Takeda did not release information about the reason for the CRL.

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