Takeda to pull key hypoparathyroidism drug from the market after years of manufacturing woes
Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.
Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.
The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional approximately 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.
Heather Novak, an author and hypoparathyroid patient who has accessed Natpara via the Special Use Program, told Endpoints News via email:
Takeda did not communicate with Special Use patients directly—and I’m devastated and terrified. While Acendis Pharma’s new PTH replacement injection, Transcon PTH, was submitted to the FDA for approval last month, unless it’s rushed, the timeline goes perfectly, and insurance approves without hesitation, I do not believe it will be a viable alternative for Special Use patients to transfer to by 2024 [Novak later clarified that she heard an approval may come next spring]. This leaves over 400 people who can’t stop taking a synthetic PTH hormone without life-threatening results without options.
Megan Ostrower, head of communications at Takeda, told Endpoints via email that the company “first consulted and aligned with regulatory authorities, and have communicated this update to patients’ prescribers. We 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, which is why we have communicated this information now.”
The difficulties with hypoparathyroidism when untreated occur due to low levels of calcium in the blood. Symptoms can range from the more mild tingling or numbness in the fingers and toes, to severe muscle cramps and spasms, as well as breathing issues that can lead to hospitalization, according to the National Organization for Rare Disorders.
And patients have explained to Endpoints many of the complications that can arise when access is lost to Natpara.
Rita McCullough of Le Center, MN, told Endpoints via email in 2021 that within a week of the 2019 recall, she ended up in the emergency department twice. She said the condition affects her breathing and she has severe muscle spasms without Natpara.
“I was crushed that I had to go back to all the pills and the alarm every two hours just so I can breathe,” she said.
McCullough, who also accessed the drug via the special use program, told Endpoints on Tuesday that she hadn’t been informed of the discontinuation prior to today’s PR.
“To say it’s concerning is an understatement!” she said.
Chrissy Bonatch of Indiana, PA, who had previously taken Natpara but was not on the special use program told Endpoints, “We feel betrayed and angry that after all this time they just dropped the ball and quit fighting for us.”
The issues and recall in 2019 for Natpara centered on rubber particulates originating from the rubber septum of the cartridge. And based on comments from Takeda on Tuesday, those particulate problems were never solved.
Takeda has continued to communicate updates about persistent supply challenges surrounding protein particle formation that are unique and specific to NATPAR/NATPARA. Over the past several years, Takeda 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. Separately, after evaluation of the U.S. Complete Response Letter received earlier this year, Takeda determined it cannot implement a solution to the rubber particle formation issue
Bob Sanders, chairman of the board of the nonprofit Hypoparathyroidism Association, previously told Endpoints that he isn’t aware of anyone who has died from a lack of access to Natpara. He said some who have lost access to Natpara are taking Eli Lilly’s Forteo off-label, while others are on calcium supplements and Calcitriol, which is not always approved by insurance companies and can create financial burdens for some patients.
“We all hope that there is no calcium crash as most hospitals lack the understanding to treat a hypopara patient because it is so rare,” Sanders said.
Takeda acquired Natpara when it bought out Shire for $62 billion in early 2019. In 2018, the last full year of Natpara sales, the treatment brought in about $230 million. Since the Natpara recall in September 2019, no US revenue has been recorded.