2022-11-20| Trials & Approvals

Provention’s Tzield Snags FDA’s Approval to Slow Type 1 Diabetes Progression

by Reed Slater
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Marking a considerable milestone for Type 1 Diabetes (T1D) patients, the FDA approved Provention Bio’s anti-CD3-directed antibody, teplizumab (brand name Tzield), as the first drug in history to slow the progression of the disease. The drug’s approval has been a long time coming after it showed potential some thirty-odd years ago, switching hands multiple times before landing in Provention’s lap, where it took the drug to the finish line. 

Reprieve for T1D Patients

The FDA approved Tzield for use in adult and pediatric patients eight years and older with stage two T1D. The regulatory agency based the approval on positive results from a clinical trial consisting of 76 patients, 44 of whom received Tzield and the remainder receiving a placebo. 

On average, the patients who received the two-week intravenous Tzield schedule developed stage 3 T1D 25 months later than those who received a placebo. The results represent a statistically significant delay in T1D progression, warranting the FDA’s approval. 

Provention designed Tzield to deactivate immune cells that attack insulin-producing cells while increasing the number of cells that help moderate the immune response. While the drug is valuable, some common adverse effects include lymphopenia, rash, leukopenia, and headache. Still, the FDA decided the benefits outweighed the risks.

The drug will not come cheap, though, with Provention’s Chief Commerical Officer, Jason Hoitt, indicating each vial would cost $13,850. With the treatment requiring 14 consecutive days of intravenous injections, a patient could expect the full schedule to cost around $194,000. Provention also said in its press release that despite delaying disease progression, when patients develop stage 3 T1D, they would require insulin injections for life.

Co-Founder and CEO of Provention, Ashleigh Palmer, said, “It cannot be emphasized enough how precious a delay in the onset of Stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications and risks associated with Stage 3 disease.”

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Teplizumab’s Long Development Journey

Long before Provention got ahold of teplizumab, the industry saw the anti-CD3-directed antibody’s potential to treat T1D. Over decades, the rights to teplizumab changed hands several times in the search to harness its therapeutic potential. 

Initially, Ortho Pharmaceuticals partnered with the University of Chicago to develop the drug before offloading it to Columbia University at some point. Then, MacroGenics Inc. came into the picture, obtaining the rights to develop the drug. 

MacroGenics put considerable effort into tailoring teplizumab to treat T1D and psoriatic arthritis. In 2007, the company partnered with pharma giant Eli Lilly to put teplizumab through its paces. The partnership would not last, though, as a Phase 3 clinical trial studying the drug’s effects on early-onset T1D failed to meet primary endpoints, prompting Lilly to abandon the project in 2010. 

Teplizumab sat in limbo for some time until Provention inked a deal with MacroGenics in 2018 to acquire the rights to the drug. At the time, Provention said it saw teplizumab’s potential in previous studies and looked to expound upon previous findings to take the drug to the next level. Now, just four years later, Provention attained the lofty goal of gaining approval for the newly branded Tzield to treat patients with stage 2 T1D. 

While Tzield does not cure diabetes, altering the progression of T1D is a major step in the right direction, providing stage 2 patients the opportunity to delay stage 3 T1D for over two years in some cases. Developing the first drug in history to delay the onset of stage 3 T1D is a huge accomplishment for Provention, which will surely use the profits from Tzield to fund other life-altering therapies. 

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