 U.S.
FDA declines to approve Provention Bio's diabetes drug
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[July 06, 2021]
(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.
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 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.
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 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.
Trading in shares of Provention Bio were halted.
(Reporting by Amruta Khandekar; Editing by
Saumyadeb Chakrabarty and Arun Koyyur)
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