USA — The U.S. Food and Drug Administration (FDA) has 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’s Tzield is an immunotherapy, which delays the progression of type 1 diabetes and will be available to patients age 8 and older who are in stage 2 of the disorder. It becomes the first drug approved to delay progression of type 1 diabetes.
In October, the company 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 US$20 million.
As per the deal, the approval will also allow Sanofi to purchase up to US$35 million of Provention’s common stock.
Teplizumab belongs to a class of drugs known as anti-CD3 therapies, which bind themselves to certain white blood cells to suppress the body’s immune response.
Type 1 diabetes is an autoimmune disease caused by the destruction of beta cells in the pancreas that produce insulin.
Approximately 30,000 patients in the United States will be eligible for the treatment. However, there could be a much larger population of undiagnosed patients.
According to Provention, there are approximately 1.4 million people in the United States who have stage 2 type 1 diabetes.
According to Jason Hoitt, Provention’s chief commercial officer, the infused treatment will have a list price of US$13,850 per vial, which works out to US$193,900 for a 14-vial continuous regimen for the average-sized patient.
The company has defended the therapy’s cost because Tzield (teplizumab) is the first drug that can delay the onset of type 1 diabetes, preventing patients from becoming insulin-dependent and vulnerable to the serious complications that can accompany advanced T1D.
It is also running the phase 3 PROTECT trial of teplizumab in newly diagnosed T1D patients, with the goal of expanding the drug’s indications. The trial enrolled 300 subjects last year, with a readout scheduled for the latter half of 2023.
The approval has also fueled speculation that Provention could become a takeover target for a diabetes specialist, with Sanofi being the most likely candidate given that it has co-promotion rights to Tzield in the US. It also has the option of acquiring global marketing rights for the drug.
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.
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