Takeda’s been looking for a buyer for Natpara to provide some debt relief, but it has just run into some complicating circumstances. It is having to recall the drug from the market, a move it says may be very challenging for patients.
Takeda today announced it was voluntarily recalling all doses of the injected drug for hypoparathyroidism in the U.S. because there was a chance of small rubber particles shedding into the injectors.
But the Japanese drugmaker was adamant that patients mustn’t stop the treatment abruptly because of the danger of a sudden drop in blood calcium levels. Instead, patients must have their doctor replace the drug with supplements and carefully monitor their calcium levels with blood tests.
“It is critically important that patients contact their prescribing healthcare provider to discuss their individual treatment plan and ensure close supervision including frequent monitoring of blood calcium levels and close titration of active vitamin D and calcium supplements upon stopping Natpara to avoid low blood calcium (hypocalcemia),” the company said.
The particles are coming from the rubber covering, or septum, in the injection cartridge. The company said that when the septum is repeatedly punctured during the 14-day treatment period, it is possible that small rubber fragments may get into the cartridge.
Takeda said it is working with the FDA to resolve the manufacturing issues that have resulted in the recall and to resume production and supply of the drug as quickly as possible.
The difficulty is that there is no alternative treatment for some patients. Natpara, a recombinant human protein, is the only drug approved in the U.S. for adults with the sometimes fatal chronic hypoparathyroidism for whom standard therapy alone is not working.
Takeda said it also is working with drug regulators in other countries where Natpara is approved, but that the drug is not being recalled in those markets at this point.
The supply interruption comes even as Takeda reportedly was looking to sell the drug as a way to improve its balance sheet after its $58 billion buyout of Shire last year. The deal was opposed by many investors because of the debt Takeda had to take on to make the buy.
Novartis provided Takeda some relief when it bought the Shire dry-eye drug Xiidra in a deal that ultimately could be worth $5.3 billion. The Swiss drugmaker also took on 400 ex-Shire employees to help it market Xiidra and the rest of its growing ophthalmic portfolio.