JDRF Statement on FDA Complete Response Letter for Teplizumab
“JDRF is thankful for the FDA’s designation of teplizumab as a breakthrough therapy and ongoing consideration of this drug. It is unfortunate that the FDA has not approved teplizumab at this time and instead has requested additional information from the sponsor.
We look forward to Provention Bio. Inc, addressing the issues outlined in the Complete Response Letter and working with the FDA to bring this option to market safely.
Disease-modifying therapies such as teplizumab will help address the unmet needs of people with T1D and those at risk for developing the disease. In the meantime, our organization will continue to support the research of other disease-modifying therapies that put us on the critical pathway to preventing and ultimately curing T1D.”