Summary
Abbott Laboratories (ABT) announced on January 14, 2011, that it has withdrawn its Biologics License Application (BLA) and European marketing authorization application (MAA) for briakinumab (ABT-874). Briakinumab was an investigational treatment for psoriasis, targeting the IL-12/23 pathway. The decision to withdraw the applications follows feedback from regulatory authorities. These authorities indicated that further analysis and potentially additional studies would be required for approval. Abbott Laboratories plans to evaluate the future of briakinumab, including the possibility of resubmitting applications at a later date.
Key Highlights
- 1Abbott Laboratories has withdrawn its US BLA and European MAA for briakinumab (ABT-874).
- 2Briakinumab is an investigational anti-IL-12/23 monoclonal antibody.
- 3The drug was being developed for the treatment of psoriasis.
- 4Withdrawal is due to feedback from regulatory authorities requiring further analysis and potential additional studies.
- 5Abbott plans to evaluate next steps for briakinumab, including potential resubmission later.
Frequently Asked Questions
Briakinumab (ABT-874) is an investigational anti-IL-12/23 monoclonal antibody that Abbott Laboratories was developing as a treatment for psoriasis.
Abbott withdrew the applications following feedback from U.S. and European regulatory authorities. This feedback suggested that further analysis and potentially additional studies would be necessary for the drug's approval.
Not necessarily. Abbott Laboratories stated they plan to evaluate next steps for briakinumab, including the possibility of resubmitting the applications at a later date after addressing the regulatory feedback.
While this represents a setback for the development of briakinumab, the filing itself is a notification of regulatory interaction and withdrawal. The full financial impact would depend on the cost of prior development and the likelihood/cost of any future resubmission efforts.