Tzield addresses the underlying cause of the disease, where the immune system destroys the insulin producing cells in the pancreas. It is administered by intravenous infusion once daily for 14 consecutive days.
Amber Specialty Pharmacy will be dispensing Provention Bio’s Tzield (teplizumab) to delay the onset of stage 3 type 1 diabetes. It is indicated for adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes. Tzield is anti-CD3-directed antibody, and binds to CD3, a cell surface antigen present on T lymphocytes. Tzield is administered by intravenous infusion once daily for 14 consecutive days.
The specialty pharmacy, Hy-Vee subsidiary, has 19 locations with ambulatory and home infusion capabilities.
“Living with or caring for a child with type 1 diabetes requires constant daily management,” Kristin Williams, president of Amber Specialty Pharmacy, said in a press release. “We understand how important it is for at-risk individuals to have access to medication and reliable support in order to delay disease progression.
The FDA approved Tzield last week. It will be available by the end of the year at a wholesale acquisition cost of $13,850 per vial for 14-day treatment course list price of $193,900, company executives said in a call with investors.
In October 2022 the company announced a co-promotion agreement for the U.S. launch of Tzield with Sanofi.