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

 
• By Alaric DeArment
  
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At nearly $194,000, the wholesale acquisition cost for Tzield came in above analysts’ $100,000-$115,000 estimates, but payer pushback is not expected as the drug faces no competition.

Provention won FDA approval for Tzield, its drug to delay onset of stage 3 type 1 diabetes • Source: Shutterstock

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...

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