The US Food and Drug Administration (FDA) has approved the use of Provention Bio’s drug teplizumab in those aged eight years and older, said Povention Bio. According to Provention Bio, the first treatment aimed at delaying the onset of type-1 diabetes dependent on insulin.
The US FDA has allowed teplizumab, to be sold under the brand name Tzield, for the patients with stage 2 diabetes who have two disease abnormality and autoantibodies in the stability of blood sugar, Provention Bio said.
Jason Hoitt, chief commercial officer of Provention Bio, said that they expect to have the drug in the channel by the end of 2022, and preparations were underway with its partner Sanofi for a full launch in the month of January 2023.
In October 2022, Provention Bio signed a co-promotion deal for the drug with Sanofi, offering the company the first negotiation for exclusive global rights to commercialize the drug in exchange for a payment of 20 million dollars. Olivier Bogillot, head of US general medicines at Sanofi, said that they expect that there is a greater value of teplizumab drug beyond the indication, and he is hoping for a broad partnership with Provention Bio in the future.
The drug is a monoclonal antibody, which supperesses the immune response of the body and the drug allows the company to produce insulin for longer, with delaying the inset of type 1 diabetes.
According to the deal, the approval will also allow Sanofi to buy up to 35 million dollars of Provention Bio’s common stock.