Trouble brewing for Provention? Shares crater after FDA says their teplizumab drug profile doesn't match that from former owner Eli Lilly
Provention Bio acquired the former Eli Lilly drug teplizumab a few years ago, hoping to bring the experimental drug back from the dead in type 1 diabetes after it flamed out in a pivotal diabetes study undertaken by the Big Pharma more than 10 years ago. But Provention is seeing troubled waters ahead following new feedback from the FDA last week.
The biotech revealed Thursday that regulators expressed concerns over the candidate’s pharmacokinetics data and comparability contained within Provention’s data package submitted to the FDA. Regulators are asserting the PK profiles of the drug manufactured by Lilly and by Provention are not the same, and asked for more data on April 2.
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