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November 3, 2022, Provention
Bio announced the latest progress of the CD3 antibody Teplizumab, which was granted breakthrough therapy certification by the FDA after resubmitting its marketing application in February this year, with a PDUFA date of November 17
.
Today, Provention received a proposal leaflet from the FDA along with post-market requirements
.
Provention said this is in line with the company's expectations and has moved further into commercial preparations
.
Affected by the news, Provention Bio's stock price soared 26% and is currently worth $686 million
.
Teplizumab submitted its first marketing application last year, but was rejected by the FDA because the PK comparability study was not conducted after the production change
.
Partner Lilly opted to return Teplizumab rights to Provention in October
Bio announced a partnership with Sanofi, which received a preferential option (ROFN) for Teplizumab for $20 million and a commitment to Provention
Bio made a $35 million equity investment
.
Although type 1 diabetes accounts for only 5% of diabetes, it has a significant impact
on the quality of life of patients due to the absolute lack of insulin due to damage to the β cells of the pancreas.
People with a family history of type 1 diabetes have a 10-15 times
higher risk.
The incidence of type 1 diabetes is increasing by 3-5% per year, with people of color significantly higher than whites
.
Type 1 diabetes can be predicted to some extent, especially in the presence of
associated islet autoantibodies.
Teplizumab is a CD3 antibody that can significantly reduce the probability of developing type 1 diabetes mellitus in high-risk groups and significantly prolong the development of insulin-dependent clinical disease (prolonging it by 2 years).
Currently, there are no drugs on the market that stop the onset or slow the progression of type 1 diabetes, and patients can only be treated
with an insulin pump.
If approved, Teplizumab would be the world's first drug
that can delay the onset of type 1 diabetes.
summary
summaryIn the United States, stage
2 There are 200,000 people at risk of potential type 1 diabetes, which is also the applicable population
of Teplizumab.
Type 1 diabetes develops earlier, and delaying onset means that the burden of disease may be delayed until the age when patients can better manage their disease, such as infancy, primary school, high school and even college, which is important for self-management of the disease
.
