FDA approval of Provention Bio’s Teplizumab could bring first disease-modifying therapy to type 1 diabetes space

If Provention Bio’s rolling Biologic License Application (BLA) submission to the FDA for teplizumab is approved, teplizumab will be the first disease-modifying therapy for type 1 diabetes (T1D). Teplizumab is one of the first therapeutics to demonstrate a disease-modifying effect for T1D. As it is a prevention therapy, it is expected to encourage early screening and earlier diagnosis, says GlobalData, a leading data and analytics company.

Samisha Khangaonkar, Pharma Analyst at GlobalData, commented: “There is no question that the prevalence of T1D is increasing. In 2016, the number of diagnosed prevalent cases of T1D across the 8 major markets (8MM*) was 3.4 million, and GlobalData expects that to grow to 4.7 million by 2026 at an annual growth rate of 3.92%. Increased screening and early treatments like teplizumab could be exactly what the market needs to drive preventative and patient specific care in T1D.”

The T1D market does not have a single marketed disease-modifying therapeutic, with current treatment relying on exogenous insulin administered daily upon diagnosis. Although the pipeline has had several promising candidates, these ultimately did not meet their clinical endpoints, so teplizumab has the opportunity to become the first disease-modifying therapy and preventative therapy for T1D.

Khangaonkar continued: “Key opinion leaders (KOLs) interviewed by GlobalData have stated that there is a considerably high unmet need for disease-modifying therapies and earlier diagnosis in T1D. Currently, patients with T1D are only diagnosed once symptoms of T1D occur. By that time, more than 80–90% of insulin-producing beta cells will have been destroyed, but evidence of beta cell autoimmunity through the presence of autoantibodies would have been present for many years prior.

“The potential approval for teplizumab is not likely to be a final treatment for T1D, but it will encourage larger players in the T1D market to focus on novel therapeutics and look further into addressing the underlying causes of T1D.

“The launch of teplizumab will force the treatment paradigm of T1D to shift by placing a greater emphasis on screening for T1D and by driving the T1D market toward precision medicine.”

*8MM: The US, France, Germany, Italy, Spain, The UK, Japan, and Canada

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