(Reuters) – The U.S. Food and Drug Administration on Tuesday rejected Prevention Bio Inc.’s approval of the experimental diabetes drug teplizumab, citing insufficient data, the company said Tuesday.
The health authority said a study in healthy volunteers comparing the proposed commercial product with the drug used in the company’s clinical trials showed no comparability.
The authority has asked the company to establish the comparability between the two products or provide other data that adequately justify why this is not necessary, said Provenion Bio.
Deficiencies related to a recent inspection at a manufacturing facility used by the company were also cited.
The company expects to collect additional comparative data later this quarter from a sub-study of the drug designed to delay clinical type 1 diabetes.
Trading in Prevention Bio shares has ceased.
(Reporting by Amruta Khandekar; Editing by Saumyadeb Chakrabarty and Arun Koyyur)
