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​​​​​​​The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.

That means a 14-day regimen of the drug would translate to a price of $193,900, the company said on a conference call.

Provention Bio entered a co-promotion agreement with Sanofi Thursday ahead of the possible November approval of Type 1 diabetes drug teplizumab.

Provention Bio will have to wait a little bit longer to see if the U.S. Food and Drug Administration will approve its diabetes prevention drug, teplizumab. On Thursday, the company announced the regulatory agency extended its review period by three months for the Biologics License Application (BLA) to Nov. 17.