The U.S. Food and Drug Administration approved the use of the drug, to be sold under the brand name Tzield, late on Thursday for delaying the onset of insulin-dependent type 1 diabetes, which is less common than type 2 of the disease, for people aged 8 years and above.
A 14-day regimen of the drug would translate to a price of $193,900, the company said on a conference call.
In October, Provention signed a co-promotion deal for the drug with Sanofi, offering the French drugmaker first negotiation for exclusive global rights to commercialize the drug in exchange for an upfront payment of $20 million.
As per the deal, the approval also allows Sanofi to purchase up to $35 million of Provention’s common shares.
Shares of New Jersey-based Provention Bio were down nearly 8 per cent before the bell.