100-mcg NATPARA will be out of supply for one year

100-mcg NATPARA will be out of supply for one year. Beginning this week, the outage of this product may last for a year.

Recently, Takeda Pharmaceutical announced in an open letter from the Hypoparathyroidism Association, wider hypoparathyroidism patients and the medical community that the supply of Natpara 100 micrograms (mcg) may be interrupted as early as the week of April 5th. Started and lasted for about a year.

“As part of our strict quality and manufacturing process, this delay in supply has affected the manufacturing and release of NATPARA 100-mcg,” said Tom Koutsavlis, the company’s head of US medical affairs and Cheryl Schwartz, head of US rare diseases.

According to the data, Takeda has notified patients currently undergoing Natpara treatment and their doctors through the company’s Special Purpose Program (SUP). Patients using the 25 mcg, 50 mcg and 75 mcg injection doses of SUP will not be affected.

Although Takeda did not specify the reason for the interruption, only that it would affect subsequent production, Takeda Pharmaceutical believes that the issue has nothing to do with the Natpara recall in the United States in 2019. The company said: “Despite progress on the initial issues that led to the U.S. recall, we still face complex challenges in bringing Natpara back to the broader patient population in the United States.”

In addition to the recall, manufacturing delays have delayed the company’s previously established timetable, and Takeda said that it does not expect to resume listing before March 31, 2022.

It is understood that Natpara injection is a recombinant human protein with a full-length 84 amino acid sequence of endogenous parathyroid hormone (PTH). It is currently approved in the United States as the only assistant for adult patients with chronic hypoparathyroidism. medicine. The FDA approved the use of Natpara together with calcium and vitamin D in the treatment of hypoparathyroidism in 2015.

There has been a recall before

In 2019, the company recalled all Natpara dosing products in the United States because of concerns that particles produced by the rubber sleeve or septum of the injector barrel may fall into the injector. Takeda said that when the cover is repeatedly pierced during the 14-day treatment period, small rubber fragments may enter the cartridge.

Because of the above recall, patients using Natpara products were affected almost immediately. It is reported that hypothyroidism is a rare calcium-consuming disease. Approximately 70,000 people are affected in the United States. Before the recall, approximately 2,800 people rely on Natpara for treatment. She added that by the end of March 2021, Takeda’s special purpose program had recruited more than 400 patients.

At the time, users of Natpara gathered on Facebook to discuss their options and worried that although Takeda was convinced that it was solving the problem, the drug might never return to the market. According to reports, in 2018, Natpara earned 230 million U.S. dollars in its latest full-year sales in the United States.

At the same time, during the inspection of the Hikari plant in November 2019, investigators also identified a malfunctioning aseptic device, which resulted in the rejection of multiple batches of products in production. Although Takeda conducted “multiple investigations” of the malfunctioning machine, subsequent tests revealed the same problem. A Takeda spokesperson told Fierce Pharma at the time that Natpara was not produced in a photochemical plant.

To some extent, this discontinued drug is a rare disease drug. “Rare” is its original sin. Highly priced rare disease drugs face problems of difficulty in marketing and payment, while drugs with too low prices face a crisis of supply suspension or even suspension; for Natpara, because there are fewer manufacturers, once a problem occurs in the production of the company, the supply will be cut off. .

(source:internet, reference only)

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