- The FDA has issued a Complete Response Letter (CRL) to Provention Bio Inc's PRVB teplizumab marketing application seeking approval for the delay of clinical type 1 diabetes (T1D) in at-risk individuals.
- The FDA stated that a single, low-dose pharmacokinetic/pharmacodynamic (PK/PD) bridging study in healthy volunteers to compare planned commercial products with drug product originating from drug substances manufactured for historical trials had failed to show PK comparability.
- The Company expects relevant additional PK/PD data to be collected from a PK/PD substudy in patients receiving 12-days of therapy in the ongoing Phase 3 PROTECT trial in newly diagnosed T1D patients later this quarter.
- Independent, unblinded third parties will analyze these data.
- In the CRL, the FDA cited additional considerations related to product quality, which the Company believes have either been addressed in amendments already submitted or can be addressed in the short term.
- The CRL acknowledged that the FDA had not reviewed several amendments already submitted by the Company in response to certain Chemistry, Manufacturing, and Controls information requests.
- The CRL did not cite any deficiencies related to the efficacy and safety data.
- The FDA requested that the Company provide a safety update as part of its resubmission.
- In April, the FDA did express concerns over teplizumab pharmacokinetics data and comparability.
- Ahead of the Adcom meeting in May, the agency said that efficacy and safety data support the benefit/risk of teplizumab.
- Price Action: PRVB shares are down 20.5% at $6.60 during the premarket session on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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