(Reuters) -The U.S. Food and Drug Administration on Tuesday declined to approve Provention Bio Inc’s experimental diabetes drug teplizumab, citing insufficient data, the company said on Tuesday.
The health regulator said a study in healthy volunteers to compare planned commercial product with the drug product used in the company’s clinical trials had failed to show comparability.
The agency asked the company to establish comparability between the two products or provide other data that adequately justifies why it would not be necessary, Provention Bio said.
It also cited deficiencies related to a recent inspection at a manufacturing plant used by the company.
The company expects to collect the additional comparability data from a sub-study of the drug, intended for the delay of clinical type 1 diabetes, later this quarter.