When the FDA approved Provention Bio’s Tzield on Thursday, it marked the end of a journey that began in 1986. It has been a journey of over 35 years for the medication to get FDA approval.
The immunotherapy, which slows the course of type 1 diabetes, will be offered to patients in stage 2 of the disease aged 8 and up. It is the first medicine to be approved to slow the course of type 1 diabetes. Tzield patients advanced from stage 2 to stage 3- an average of 25 months later than placebo patients. When you reach stage 3, you face serious health concerns, including ketoacidosis’s potentially deadly consequences.
Director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, John Sharretts stated: “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients. The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”
Approximately 30,000 people in the United States will be eligible for the therapy. However, there might be a considerably bigger group of undiagnosed patients. According to Provention, approximately 1.4 million people in the United States have stage 2 type 1 diabetes.
According to Jason Hoitt, the CCO of Provention, the infused therapy will have a list price of $13,850 for each vial, which works out to $193,900 for a 14-vial continuous regimen for the average-sized patient. Thomas Smith, an analyst in an investor letter stated that they were shocked to see the number close to $200,000.
During the call, Provention CEO and founder Ashleigh Palmer stated:
“This is not another symptomatic monoclonal antibody that treats symptoms better than the prior one. This is a game-changing breakthrough invention that offers therapy to stage 2 type 1 diabetes patients who previously had no choice except to wait for the condition to worsen.”
Provention said last month that it had agreed with Sanofi to sell the medicine in the United States. When other nations approve Tzield, Sanofi will pay $35 million to Provention and an additional $20 million to obtain the opportunity to initially negotiate exclusive worldwide marketing rights.
After failing a late-stage experiment, the medication moved from MacroGenics to Eli Lilly in 2007 and subsequently to Provention in 2011. It lay on the shelf at Provention until, at Bluestone’s urging, the New Jersey-based firm gave it another attempt based on lessons gained from the first round. Bluestone finally joined the Provention board of directors in 2019.
Sanofi will allow Provention to call on its diabetic field specialists and account directors, as well as field-based reimbursement and medical science liaisons, as part of the agreement, which should help Provention build its Rolodex of local healthcare professionals in the field. The approval would be a huge success for the University of California’s immunologist, Jeff Bluestone, as he is the initiator of the study which led to the successful innovation of teplizumab.