Takeda's rare disease drug's manufacturing and supply woes continue as FDA rejects supplement
Almost 3 years after Takeda had to recall a drug that can help people with the rare condition known as hypoparathyroidism, those waiting for any sign that supplies of their reliable injection from Takeda might reemerge will have to wait even longer.
Takeda announced on Tuesday that the FDA rejected its Prior Approval Supplement (PAS) submitted last August to address the formation of rubber particulates that led to the initial recall in September 2019.
More than 2,000 people have been stranded without Natpara (parathyroid hormone) as they do not have access to the company’s Special Use Program (SUP), which is only for about 400 of those who are at extreme risk of life-threatening complications. But when those manufacturing issues will be resolved remains an open question. The company previously said that it might resume supply by next week, but now that forecast has been thrown out.
Light on details in its announcement on the CRL, Takeda did make clear that it will continue to provide access to Natpara free of charge via the SUP, and that product will be supplied under the discretion of the FDA and until commercial product is available. The company also explained separate manufacturing issues it’s addressing related to Natpara and said it’s taking a deeper look at the CRL:
With the goal of limiting supply interruption for SUP patients, we continue to work on the separate supply challenges surrounding protein particle formation that we have described over the past year. Those challenges are unrelated to the PAS and the recall. It is important to underscore that all product released for patient use continues to meet Takeda’s quality standards and the safety profile of NATPARA has not changed.
Takeda acquired Natpara when it bought out Shire for $62 billion in early 2019. In 2018, the last full year of Natpara sales, the treatment brought in about $230 million. Since the Natpara recall in September 2019, no US revenue has been recorded and concerns are growing among patients that the drug may never return to market.
Heather Novak, a Michigan-based author who takes Natpara to treat her hypoparathyroidism, told Endpoints News via email that she currently does still have access to her dose and supplies thanks to the SUP. “I have friends on higher doses who have shifted strengths because of the shortages, but I am thankfully not one of them,” she said.