Takeda’s letter to Healthcare Providers: see below.
My summary: A Prior Approval Supplement (PAS) that proposes a new septum and new needle to address the rubber particle issue has been submitted to the FDA. Approval would resolve the rubber particle issue. The approval process typically takes 4-6 months but may take longer.
The letter, however, also notes the additional supply and manufacturing issue that is a different problem and that also needs to be solved to bring NATPARA back on the market.
Dear Healthcare Provider,
The purpose of this communication is to provide a regulatory filing update for NATPARA® (parathyroid hormone) for Injection in the US. No action is required by you, however we are sharing this information for your awareness because your patient(s) enrolled in the Special Use Program (SUP), as well as many patients previously prescribed NATPARA, will also be receiving this update.
Takeda has submitted a Prior Approval Supplement (PAS) to the US Food & Drug Administration (FDA) as the next step in the Company’s efforts to address the issue of rubber particulates originating from the rubber septum of the NATPARA cartridge that led to the US recall in September 2019. The submission proposes device component changes that include a new septum and new needle. US regulatory approval of the PAS is a critical step to bringing NATPARA back in the US, as the proposed changes are required to enable US patient use per the approved NATPARA labeling, which includes 14-day administration.
As our leadership team shared during the April 2021 community call, there are a few potential regulatory outcomes from FDA’s review of this submission. Once FDA completes their review, the outcomes could include: 1) regulatory approval; 2) regulatory feedback that may require changes to our approach; or 3) significant regulatory feedback that may lead to starting the process over again. While Takeda is optimistic about the approach we have submitted to FDA, the timeline and outcome are still uncertain.
The next step in the regulatory process is for FDA to review our submission, which typically takes four to six (4-6) months after a PAS has been filed. This timeline could be extended should additional data or alternative proposals be required following regulatory discussions.
In addition, the supply and manufacturing issues that we described during the April call are separate from the issue that led to the US recall and remain complex. As we continue to work with urgency to address those issues, it is important to underscore that a potential FDA approval of the PAS is not the only variable that will determine how soon we can return NATPARA to the broader patient community. Our ability to provide a stable and consistent supply of NATPARA will also be a critical factor and remains an area of focus. Patients enrolled in the SUP continue to have access to NATPARA in the US through that Program.
We will plan to provide another update that includes the anticipated regulatory review timeline and a status update on the manufacturing/supply issues before the end of the 2021 calendar year. We understand how difficult the past two years have been for the community, and we remain committed to keeping you updated as we make progress in our efforts to bring NATPARA back.