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FDA rejects remarketing of Takeda's parathyroid hormone Natpara

 Last Update: 2022-04-29
 Source: Internet
 Author: User

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A few days ago, the U.
S.
FDA rejected the re-marketing of Takeda’s parathyroid hormone Natpara, and the newly released Complete Response Letter (CRL) also completely broke the company’s vision of re-marketing this parathyroid hormone injection
.

Natpara is a drug developed by Takeda to help patients cope with hypocalcemia caused by hypoparathyroidism, and it is also the first prescription parathyroid hormone approved by the US FDA
.

However, in September 2019, Takeda finally had to announce a recall of all batches of Natpara injectable products in the U.

During the 14 days of Natpara treatment, the patient was given daily injections after piercing a rubber septum with a needle
.

Repeated piercing operations could have directly caused pieces of rubber on the cartridge to detach, and Takeda claimed at the time that the detached rubber stopper could clog the needle and result in an insufficient dose of the drug injected into the patient's body.

In August 2021, in order to make up for the impact of the recall and move Natpara back to market as soon as possible, Takeda submitted a pre-approval supplement (PAS) for Natpara to U.
S.
regulators, hoping to address the rubber pellet issue
.

The company proposed changes to the Natpara device components, including a new septum and a new needle

However, despite efforts to correct Natpara's safety concerns, the FDA noted in its recent full response letter to Takeda that the PAS application cannot be approved under the current circumstances
.

Takeda said that the company will evaluate the specific details of the CRL to determine the next step

Natpara, first approved by the FDA in September 2015, is used with calcium and vitamin D to control abnormally low levels of calcium in people with hypoparathyroidism
.

Natpara helps the gut absorb more calcium by activating vitamin D, while increasing the amount of calcium reabsorbed by the kidneys, and also promotes the release of necessary calcium from the bones

At present, although it is difficult for Natpara therapy to return to the commercial market in the short term, Takeda intends to continue to provide the drug free of charge to patients already enrolled in the Natpara Special Therapeutic Use Program, and the US FDA has also provided the necessary regulatory oversight and discretion for this purpose.

.

The Natpara Special Use Program was implemented following the September 2019 recall of the drug to help patients previously treated with Natpara to continue using the drug and avoid potentially life-threatening complications from abrupt discontinuation

Reference source: Return of Takeda's Parathyroid Hormone Injection Delayed Indefinitely

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