Teplizumab's approval will be paradigm changing for type 1 diabetes, says analyst

The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee recently voted in favor of USA-based Provention Bio’s (Nasdaq: PRVB) teplizumab by 10 yes to 7 no, on the question: "Does the information provided in the background documents and presentations by the Applicant and FDA show that the benefits of teplizumab outweigh the risks in support of approval to delay clinical type 1 diabetes mellitus?"

In the eight major markets (8MM; the USA, France, Germany, Italy, Spain, the UK, Japan, and Canada) the number of diagnosed prevalent cases of T1D will grow at an annual growth rate (AGR) of 1.78%, from 3.3 million cases in 2019 to 3.9 million cases by 2029, according to GlobalData. The data and analytics company notes that, as these cases increase, there is still no approved disease-modifying treatment for T1D, and teplizumab will likely not only be the first preventative therapeutic, but the first disease-modifying therapeutic for T1D.

Could be first preventative treatment for T1D by year end