Takeda will stop manufacturing its medication Natpara for a rare endocrine condition at the end of 2024 after failing to resolve longstanding production issues.
The Japanese drugmaker has struggled with persistent supply challenges posed by the unique manufacturing process for the drug, a bioengineered replica of human parathyroid hormone. Takeda has also been unable to find a way to prevent contamination of rubber particles from the drug’s injector cartridge.
For years it has explored solutions for both issues, but “despite these efforts, Takeda has unfortunately determined there is not a sustainable or viable path forward,” the company said Tuesday.
Natpara treats low levels of parathyroid hormone in patients with hypoparathyroidism, a rare condition that leads to low blood calcium levels and related health problems in an estimated 70,000 people in the U.S.
For patients who cannot control their blood calcium levels with calcium and Vitamin D supplements, the loss of the drug leaves them without alternate medications. In addition, patients who abruptly stop taking Natpara can suffer from serious complications such as severe pain, kidney damage and cardiac events.
The announcement comes after three years of setbacks with the drug since Takeda acquired it via its $62 billion takeover of Shire in 2019.
In September 2019, the rubber contamination issue led Takeda to issue a U.S. recall, pulling the drug from the market. Patients taking the drug maintained access to it through a Food and Drug Administration special use program. The company in early 2021 said it would take another year for the drug to return to the U.S. market, but a year later the FDA rejected its application.
The FDA approved Natpara in 2015, weeks after its manufacturer NPS Pharma agreed to be bought by Shire.
Now, Takeda said its priority is to maintain supply for patients taking the drug in the U.S, Europe (where it is sold as Natpar) and other regions, and after 2024, until inventory is depleted or expired. The company said it “has great empathy for hypoparathyroidism patients who rely on Natpar/Natpara and deeply regrets that we could not resolve these issues.”
There are around 420 patients enrolled in the U.S. special use program, a Takeda spokesperson told BioPharma Dive.
“After consultation and alignment with regulatory authorities, we have communicated this update to patients' prescribers and are reaching out directly to all patients enrolled in the U.S. Special Use Program to allow for these patients to consult with their healthcare teams to develop longer-term treatment plans,” the company said in an emailed statement.