Tzield, the World's First USFDA approved drug to delay type 1 diabetes onset to cost more than Rs 11 lakh per vial, confirm makers
New Jersey: With the recent USFDA, approval of the first drug to delay type 1 diabetes onset, teplizumab, makers of the drug Provention Bio Inc on Friday its stated that the drug sold under the brand name Tzield would cost $13,850 a vial ( Rs 11,29,054 approximately).Medical Dialogues drug had recently reported that the U.S. Food and Drug Administration approved the use of the drug, to be...
New Jersey: With the recent USFDA, approval of the first drug to delay type 1 diabetes onset, teplizumab, makers of the drug Provention Bio Inc on Friday its stated that the drug sold under the brand name Tzield would cost $13,850 a vial ( Rs 11,29,054 approximately).
Tzield binds to specific immune system cells and delays progression to stage 3 type 1 diabetes. It may deactivate the immune cells that attack insulin-producing cells and increase the proportion of cells that help moderate the immune response. The administration of Tzield is via intravenous (IV) infusion once daily for 14 consecutive days.
A 14-day regimen of the drug would translate to a price of $193,900, the company said on a conference call.
What is Tzield (teplizumab) ?
TZIELD (teplizumab-mzwv) is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D. TZIELD injection is supplied as a sterile, preservative-free, clear and colorless solution in a 2 mg/2 mL (1 mg/mL) single-dose vial for intravenous use. TZIELD should be administered by intravenous infusion (over a minimum of 30 minutes) once daily for 14 days. Please see full prescribing information for the dosing schedule.
Tzield's safety and efficacy were evaluated in a randomized, double-blind, event-driven, placebo-controlled trial with 76 patients with stage 2 type 1 diabetes. In the trial, patients randomly received Tzield or a placebo once daily via intravenous infusion for 14 days. The primary measure of efficacy was the time from randomization to development of stage 3 type 1 diabetes diagnosis. The trial results showed that over a median follow-up of 51 months, 45% of the 44 patients who received Tzield were later diagnosed with stage 3 type 1 diabetes, compared to 72% of the 32 patients who received a placebo. The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes.
The most common side effects of Tzield include decreased levels of certain white blood cells, rash and headache. The use of Tzield comes with warnings and precautions, including premedicating and monitoring for symptoms of Cytokine Release Syndrome; risk of serious infections; decreased levels of a type of white blood cell called lymphocytes; risk of hypersensitivity reactions; the need to administer all age-appropriate vaccinations prior to starting Tzield; as well as avoiding concurrent use of live, inactivated and mRNA vaccines with Tzield.
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