After years of manufacturing woes, Takeda is calling it quits on Natpara

After an indefinite commercial delay on its Shire-acquired rare disease drug this spring, Takeda’s yearslong Natpara manufacturing saga is drawing to a close.

The Japan-based pharma has elected to nix all manufacturing of its Natpara injection for hypoparathyroidism in the U.S. and abroad by the end of 2024, a decision it credited to “unresolved supply issues that are specific to the product.” In the wake of that manufacturing halt, Takeda says it won’t put Natpara back on the market in the states or make the drug anywhere else globally.

Natpara, known generically as parathyroid hormone, is marketed under the Natpar brand internationally. Takeda acquired the rare disease med in its $62 billion buyout of Shire.

Takeda has been struggling to right the ship on Natpara’s manufacturing since it first recalled the medicine in the U.S. back in 2019. As the forecast for Natpara’s revival slipped from 2021 to 2022, the severity of the production hitch became clearer.

At the same time, many of the roughly 2,800 patients who relied on Natpara before the recall have made their concerns known.

At the end of March 2021, just over 400 patients were still receiving the drug under a Takeda special use program, a company spokesperson told Fierce Pharma at the time. In April of that same year, Takeda warned Natpara supplies might run low for some patients on the program, tying the shortfall to a manufacturing delay separate from the rubber particulate fears that prompted the med’s mass recall in 2019.

Natpara—and hypoparathyroidism patients—took another blow this spring when the FDA dealt Takeda a Complete Response Letter. The FDA rebuke prompted Takeda to admit Natpara’s commercial return in the U.S. was “indefinitely delayed.”

In announcing its new plan to terminate Natpara in the U.S. for good, meanwhile, Takeda said it has “great empathy for hypoparathyroidism patients who rely on NATPAR/NATPARA and deeply regrets that we could not resolve these issues.” The company explained it “is communicating this information now following consultation and alignment with regulatory authorities and to allow time for patients to consult with their healthcare teams to develop longer-term treatment plans.”

Until the end of 2024, Takeda says maintaining treatment continuity for patients currently on Natpara will be priority No. 1, “subject to available supply.”

Beyond 2024, Takeda says it intends to supply the doses it has left until inventory is depleted or expired. The company also pledged to provide updates prior to the end of manufacturing “and ahead of any potential supply interruptions.”

While Takeda has been tight-lipped about some of its more recent Natpara production hang-ups, the company in its latest release spoke candidly about its continued battle with particle formation unique to Natpara, rubber and otherwise.

The company stressed that it’s explored multiple routes to address the Natpara protein particle issue. The company also conceded that after the receipt of its Complete Response Letter earlier this year, “it cannot implement a solution to the rubber particle formation issue.’

Takeda added that despite its best efforts, the company doesn’t see a “sustainable or viable path forward” for the rare disease med.

In 2018, the last full year Natpara’s U.S. sales were reported, the drug earned $230 million.