Drug for delaying diabetes wins landmark approval
Credit: MEHMET TAYLAN / Alamy Stock Photo
But Tzield does not come cheap. With a sticker price of nearly $200,000 for a full course of treatment, the humanized CD3-directed IgG1 monoclonal antibody from Provention Bio might only be a cost-effective option for at-risk individuals with certain genetic and immune characteristics,. And finding those individuals could prove challenging given that few places have mass screening protocols in place to identify would-be beneficiaries.
Herold is the chair of TrialNet, an academic consortium that led the registration-enabling trial of Tzield, which measured the time from baseline to T1D diagnosis among people at high-risk who had relatives with the disease. In that 76-person study, drug treatmentby a median of nearly three years — from 27.1 months among placebo recipients to 59.6 months among those who got Tzield — with side effects that included blood count abnormalities, rashes and headaches.
Tzield is approved for anyone 8 years of age and older with blood work showing two or more autoantibodies against either pancreatic islet cells or the insulin hormone; patients should also be showing signs of impaired sugar metabolism, as measured by an oral glucose tolerance test or by another method. Recipients don’t need to have a family member with T1D to be eligible for the therapy, as they did to participate in the TrialNet study.
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