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www.fdanews.com/articles/203497-provention-bios-teplizumab-approval-in-jeopardy

Provention Bio’s Teplizumab Approval in Jeopardy

July 9, 2021

On its long slog toward FDA approval, teplizumab, a monoclonal antibody being developed for delaying or preventing type 1 diabetes, has stumbled over bioequivalency concerns.

Teplizumab’s healthy volunteer bridging study didn’t prove pharmacokinetic (PK) equivalence with the original Eli Lily-manufactured product used in pivotal trials, according to FDA’s Complete Response Letter (CRL), portions of which manufacturer Provention Bio has shared.

Originally a child of Eli Lily, teplizumab was abandoned after it failed to meet efficacy endpoints in a late-stage clinical trial in 2010. Provention acquired it from co-developer Macrogenics in 2018.

To move forward, the CRL noted, Provention “will need to establish [pharmacokinetic] comparability appropriately between the intended commercial product and the clinical trial product or provide other data that adequately justify why PK comparability is not necessary.”

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