U.S. FDA greenlights Provention Bio's diabetes drug

FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland

By Bhanvi Satija

(Reuters) - Provention Bio said on Thursday the U.S. Food and Drug Administration had approved the use of its drug teplizumab in those aged eight years and older, the first treatment aimed at delaying the onset of insulin-dependent type 1 diabetes.

The U.S. health regulator has allowed teplizumab, to be sold under the brand name Tzield, for patients with stage 2 of the disease who have two or more disease autoantibodies and abnormality in blood sugar stability, Provention Bio said.

"We expect to have drug in the channel by the end of the year," said Jason Hoitt, Provention's chief commercial officer, adding that preparations were underway with its partner Sanofi for a full launch in January 2023.

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.

"We expect that there is a greater value of teplizumab beyond this indication and hope for a broader collaboration with Provention in the future," said Olivier Bogillot, Sanofi's head of U.S. General Medicines.

As per the deal, the approval will also allow Sanofi to purchase up to $35 million of Provention's common stock.

Current standard of care for type 1 diabetes requires patients to monitor and manage symptoms such as low or high blood sugar levels through regular insulin intake.

The injectable drug, for which Provention acquired rights from MacroGenics Inc in 2018, is a monoclonal antibody that suppresses the body’s immune response and allows it to produce insulin for longer, thereby delaying the onset of type 1 diabetes.

Type 1 diabetes, previously known as juvenile diabetes, is a disease in which the immune system attacks and destroys the insulin-producing beta cells in the pancreas, leaving sufferers reliant on regular insulin injections.

(Reporting by Bhanvi Satija and Nandhini Srinivasan in Bengaluru; Editing by Vinay Dwivedi and Maju Samuel)