Takeda’s long slog to manufacture and relaunch its hypoparathyroidism drug Natpara got a lot tougher after the pharma giant announced it received a new complete response letter from the FDA.
The CRL comes in response to the steps Takeda outlined last August in a prior approval supplement (PAS) to address the potential of rubber particulates to form in the medicine. The issue prompted a 2019 U.S. recall of Natpara.
Takeda issued the recall on concerns that rubber from the covering of the injector cartridge could shed into the injectors. When the covering is repeatedly punctured over the 14-day treatment period, small rubber fragments can make their way into the cartridge.
Takeda said it is evaluating the FDA response letter in order to decide its next steps. The drugmaker is “deeply disappointed to inform the hypoparathyroidism community that Natpara’s commercial return in the U.S. is indefinitely delayed.”
Since there are currently no other FDA-approved treatment alternatives for chronic hypoparathyroidism patients, the company said it will provide patients who are enrolled in its special use program (SUP) for Natpara access to the therapy free of charge in accordance with the FDA “until a commercial product is available.”
Patients began feeling the supply squeeze on Natpara last April when Takeda announced a shortfall of the treatment due to a manufacturing delay that was unrelated to the rubber particulate issues that triggered the recall.
“With the goal of limiting supply interruption for SUP patients, we continue to work on the separate supply challenges surrounding protein particle formation that we have described over the past year,” the company said in its latest statement.
Hypoparathyroidism is a rare, calcium-depleting disease that affects about 70,000 people in the U.S. More than 2,800 patients were using Natpara before the 2019 recall, the company said at the time. A little more than 400 patients were enrolled in the company’s special use program as of March 2021.