Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara. Natpara is intended to help patients navigate low blood calcium due to hypoparathyroidism.
In Sept. 2019, Takeda issued a U.S. recall of all natpara for injection due to a potential for rubber particulate stemming from the rubber septum of the natpara cartridge. In response to the recall, Takeda submitted a Prior Approval Supplement (PAS) for natpara in Aug. 2021 to address the potential for rubber particulate formation. The submission proposed a device component change to include a new septum and a new needle.
Despite its efforts to rectify the issues with natpara, Takeda received a Complete Response Letter (CRL) from the FDA stating that the PAS could not be approved in its present form, delaying the commercial return of natpara indefinitely. Read more here.