Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
Provention Bio’s new injectable drug was recommended by an FDA committee for approval on May 25, 2021. Studies show that teplizumab can delay, for people at risk for type 1, the onset of the condition for two years or more. Learn what happened at the FDA meeting and what might come next.
Rarely does one get to witness the potential for an entirely new therapeutic or preventive drug come onto the medical horizon. But that is the threshold we have now reached with the possible approval by the U.S. Federal Drug Administration (FDA) of the first drug that attempts to delay the onset of type 1 diabetes (T1D) – teplizumab.
Some questions remain to be seen: whether there is enough data, whether the data is sufficiently compelling, and whether the risk-to-benefit ratio is favorable enough for the FDA to grant teplizumab’s approval. To address these issues, the FDA convened an Endocrinologic and Metabolic Drugs Advisory Committee Meeting (EMDAC) on May 27, 2021.
diatribe.org
Rarely does one get to witness the potential for an entirely new therapeutic or preventive drug come onto the medical horizon. But that is the threshold we have now reached with the possible approval by the U.S. Federal Drug Administration (FDA) of the first drug that attempts to delay the onset of type 1 diabetes (T1D) – teplizumab.
Some questions remain to be seen: whether there is enough data, whether the data is sufficiently compelling, and whether the risk-to-benefit ratio is favorable enough for the FDA to grant teplizumab’s approval. To address these issues, the FDA convened an Endocrinologic and Metabolic Drugs Advisory Committee Meeting (EMDAC) on May 27, 2021.
Teplizumab: Can We Delay the Onset of Type 1?
Provention Bio’s new injectable drug, which was recommended by an FDA committee for approval on May 25, 2021, has had a tumultuous journey through the FDA application process. Studies showed that teplizumab can delay the onset of type 1 diabetes – for people already at high risk – for two years...
