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Takeda's rare disease med Natpara faces long road back to market as manufacturing issues multiply

Apr 5, 2021 2:53pm
Starting this month, supplies of Natpara 100 mcg could run short for patients on Takeda s special use program, the company said in a recent letter.
Takeda’s ongoing struggle to manufacture the hypoparathyroidism drug Natpara snared in its $62 billion Shire buyout has worn on for more than year. Now, a second production hangup could delay the rare disease med s return to market until at least 2022.
Starting the week of April 5, Natpara supplies may run short for patients receiving the 100-mcg dose of the drug through the company s special use program (SUP), Takeda said in a recent letter. Takeda tied the shortfall to a manufacturing delay separate from the rubber particulate fears that prompted a mass recall of the injectable in 2019. ....

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Bring back Natpara: FDA must help hypoparathyroidism sufferers

This suffering can’t continue. It’s time for FDA officials to realize how profoundly debilitating this condition is, stop dragging their feet, and give patients additional and better treatment options.
Hypoparathyroidism occurs when the parathyroid glands located on the thyroid glands in people’s necks are either removed, injured or can’t produce the parathyroid hormone for genetic reasons. Most people develop the disease after surgery. Patients with this condition often experience unstable and fluctuating calcium levels.
When blood calcium levels drop too low, patients can experience “calcium crashes,” a dangerous complication that causes people to have seizures or act delirious. Sadly, these calcium crashes are all too common almost 70% of hypoparathyroidism patients have experienced a calcium crash in the past year. Over 40% suffered calcium crashes as often as weekly. ....

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