Provention Plans Two-Phase Launch Of Tzield, Pricing Drug Higher Than Expected

Provention Bio, Inc. plans to launch Tzield (teplizumab-mzwv) for delaying onset of stage 3 type 1 diabetes (T1D) in two phases, starting with those in stage 2 with a familial history of the disease before branching into the stage 2 population more broadly. Although labeling does not carry a family-history restriction, the company has identified that segment as the “most addressable” for the initial launch. The drug’s price point came in significantly higher than analysts had anticipated, but its monopoly on the approved indication makes it unlikely payers will set restrictions.

The US Food and Drug Administration granted full approval to Tzield on 17 November, for use in patients who currently have stage 2 of T1D. The approval was based on data from the randomized, placebo-controlled Phase II TN-10 trial that enrolled 76 patients ages 8-49 years with stage 2 of the disease, as defined by presence of two or more disease-related autoantibodies and dysglycemia