Takeda has issued a letter to the hypoparathyroidism community confirming that the COVID-19 pandemic will NOT impact Natpara Special Use Program supply, Special Use Program applications or the development activities in progress that will support Natpara's return to the US market.
Please click the link for a letter issued by Takeda regarding the potential time frame for the return of Natpara to the US market. While discussions with FDA are ongoing, required work and testing are likely to delay the return by more than a year. The Special Use Program will continue for patients who are at risk of life-threatening complications without Natpara. Takeda will keep the community informed as new information becomes available.
Takeda issued a letter to the hypoparathyroidism community to update on the status of discussions with FDA around the Special Use Program and proposals for plans that will allow the return of Natpara to the market.
This is a summary of the questions, answers and topics that were discussed at the Takeda Q&A Roundtable session at the International Hypoparathyroidism Association Patient Conference in Denver, CO (Oct 2019)
Ascendis Pharma has released an important update to the PaTH Forward Clinical Trial! As many of you may know, PaTH Forward is a phase II study to assess TransCon PTH in patients with hypoparathyroidism and which initially required patients to be discontinued from any PTH therapy for 12 weeks before being eligible to enroll. In order to better address the unmet needs of our community, Ascendis has amended the study to allow patients impacted by the Natpara recall to have an expedited pathway to enroll in the study. In addition, they will allow the study enrollment to exceed the target of 40 patients. The Hypoparathyroidism Association is excited that the efforts of Ascendis will provide a much needed option to many patients during this difficult time and we are grateful for their continued dedication and unparalleled commitment to the hypopara community! Patients interested in participating in the PaTH Forward trial can speak to their physician or go to www.pathforwardtrial.com.
Takeda has been notified by FDA that the recall of Natpara has been classified as a Class 1 recall. This means that patients will be asked to return all unused Natpara once they have discontinued use in line with instructions from their prescribing health care provider. This does not apply to patients who received single use cartridges under the Special Use program! Please click on the Title to be redirected to Takeda's Newsroom for.
The Hypoparathyroidism Association is very pleased to inform you that Takeda and FDA have developed a Special Use Program for patients in life-threatening situations to be granted access to Natpara while the product recall is in effect. This program can be requested by a physician and will be evaluated by an adjudication committee who will determine if the patient qualifies. Takeda will be issuing a statement momentarily with further details, which the Association will share. This is an unprecedented type of program and really proves how committed Takeda and FDA are to the hypopara community and how they are exercising ingenuity and flexibility to overcome these difficult challenges!
The Endocrine Society and the American Society for Bone Mineral Research (ASBMR) have released a statement on the Natpara recall, which includes guidance for physicians on discontinuation of Natpara.
Takeda Update from Sept 17 Meeting
A message from Takeda regarding the US recall of Natpara
This list of questions is intended to help patients work with their doctors to develop a plan for discontinuation of Natpara. It was compiled by The Hypoparathyroidism Association with oversight from our medical advisers. It is not intended as medical advice.
Letter of support from the Association Board for Natapara patients affected by the recent recall.
A note from The HypoPARAthyroidism Association regarding the Natpara recall
Click the header to download Takeda's health care provider letter regarding Natpara Recall
Click the header to download Takeda's patient letter regarding Natpara Recall