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The U.S. Food and Drug Administration (FDA) regulatory review is now under way for teplizumab—a therapy that blocks the blood marker CD3, which activates immune cells—to prevent or delay type 1 diabetes (T1D) in at-risk individuals. The target action date is July 2, 2021.

Teplizumab could become the first disease-modifying therapy approved for T1D.

Breakthrough T1D had a hand in the development of teplizumab from nearly the beginning:

Teplizumab, now called PRV-031, is also being tested in a phase III clinical trial in people who have been recently diagnosed, headed by Provention Bio, a company with an investment from the Breakthrough T1D T1D Fund.

If successful, and the FDA review results in approval, we will be moving ever closer to a world without this disease.