The Food and Drug Administration’s potential breakthrough drug for diabetes — which has the capacity to delay the onset of Type 1 diabetes — could be ready for high-risk patients before January.
According to The New York Times, Tzield (or teplizumab) became the result of an exploratory partnership between Provention Bio and Sanofi.
Also, the Times reports that a 14-day prescriptive treatment of Tzield could have a price tag in the neighborhood of $194,000.
And for a single-day vial of the advanced drug, the reported cost comes to $13,850.
The 14-day “infusion” of Tzield, per the Times, involves a monoclonal antibody “that blocks T cells” and subsequently prevents any attacks of the insulin-producing cells of the pancreas.
With adults, Tzield could delay the onset of Stage 3, Type 1 diabetes, according to FDA reports.
For pediatric patients 8 and above, Tzield could most benefit those in that age range with Stage 2, Type 1 diabetes.
The same FDA report notes that Tzield doesn’t serve as a cure or prevention of Type 1 diabetes, which commonly occurs among teenagers.
“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” Dr. John Sharretts, head of the diabetes division at the FDA’s Center for Drug Evaluation and Research, said in his Thursday statement.
“The drug’s potential to delay clinical diagnosis of Type 1 diabetes may provide patients with months to years without the burdens of disease,” added Sharretts.
According to Drugs.com, Tzield could be a game changer for Stage 3, Type 1 diabetes patients, or those who can’t produce enough insulin on their own and may require insulin injections.
Type 1 diabetes “is an autoimmune disease characterized by gradual destruction of beta cells in the islets of Langerhans. Tzield is an anti-CD3 monoclonal antibody that works by interfering with the destruction the beta cells,” writes Drugs.com.
Also, Tzield might cause a “decrease” in a type of white blood cell called lymphocytes — a common, yet potentially serious side effect which could hinder a person’s ability to ward off infections.
As the Times points out, Type 1 diabetes screening is largely viewed as a fruitless venture, since roughly 4 out of every 1,000 people — or 1.4 million Americans — encounter this rare disease.
Reporting by Newsmax.
