Drugs

Manufacturing Woes Lead to Natpara Discontinuation

Takeda says it will discontinue manufacturing Natpara (parathyroid hormone) for injection due to manufacturing woes that caused protein particle formation that has led to earlier recalls of the product. The company expects to continue making the product, which is indicated for treating hypoparathyroidism, until the end of next year, and then provide product supplies until inventory is depleted thereafter.

Takeda says that over the past several years, it has “explored numerous ways to address the Natpar/Natpara protein particle issue to improve sustainable supply. Some of the specific steps have included focused root cause analysis, computational modeling, evaluation and implementation of manufacturing process changes and reformulation research and development.”

Earlier this year (see story), FDA issued a complete response letter on a Natpara prior approval supplement submitted in 8/2021 to address the potential for rubber particulate formation that led to a U.S. Natpara recall in 9/2019. The company said FDA indicated it could not approve the supplement in its present form. Takeda also said at the time that because there were no FDA-approved treatment alternatives for chronic hypoparathyroidism patients, it intended to provide patients enrolled in the Natpara special use program with continued access to free therapy under FDA oversight and direction until a commercial product became available.

Now, Takeda says after evaluating the letter it determined it cannot implement a solution to the rubber particle formation issue. “Despite these efforts, Takeda has unfortunately determined there is not a sustainable or viable path forward,” it says. “It is important to underscore that all product released for patient use continues to meet Takeda’s quality standards, and the safety profile of Natpar/Natpara has not changed.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome