Briakinumab (original) (raw)
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Monoclonal antibody
Pharmaceutical compound
Briakinumab
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | IL-12 and IL-23 |
| Clinical data | |
| ATC code | L04AC09 (WHO) |
| Legal status | |
| Legal status | investigational |
| Pharmacokinetic data | |
| Bioavailability | N/A |
| Identifiers | |
| CAS Number | 339308-60-0  N |
| ChemSpider | none |
| UNII | 978I8M0P8X |
| Chemical and physical data | |
| Formula | C6376H9874N1722O1992S44 |
| Molar mass | 143935.83 g·mol−1 |
N Y (what is this?) (verify) |
Briakinumab (ABT-874) is a human monoclonal antibody being developed by Abbott Laboratories for the treatment of rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis. As of 2011 drug development for psoriasis has been discontinued in the U.S. and Europe.[1]
Like ustekinumab, the antibody targets the interleukins 12 and 23.[2]
The candidate drug was discovered by Cambridge Antibody Technology in collaboration with Abbott.[3][4]
As of November 2009[update], Phase III clinical trials for plaque psoriasis[5][6] and a Phase II trial for multiple sclerosis[7] have been completed, and a Phase II trial for Crohn's disease is underway.[8]
Briakinumab was compared to etanercept and placebo in several double-blind trials. The Psoriasis Area Severity Index (PASI) was reduced significantly better than under the comparator treatments. 81–82% of patients under briakinumab, 40–56% under etanercept, and 7% under placebo reached PASI reduction of at least 75%.[9] No head-to-head studies against ustekinumab, the other IL-12/23 inhibitor, are available.
On January 15, 2011, Abbott announced the withdrawal of its application to the US FDA and European regulators for briakinumab. Following feedback from regulatory authorities indicating the need for further analysis, including the potential for additional studies, Abbott withdrew its applications and was evaluating next steps including possible resubmission at a later date. This compound has never been resubmitted for approval.
This is the second candidate from a deal with Cambridge Antibody Technology that Abbott have taken to late-stage clinical trials. As a result of the protracted royalty dispute over Humira Abbott agreed to pay CAT a reduced royalty of 4.75% on any future sales of ABT-874, from which CAT will pay a portion to the MRC and other licensors (according to CAT's 1997 agreement with the MRC).[10]
- ^ "Abbott withdraws briakinumab applications in USA, Europe". PharmaTimes. 17 January 2011. Archived from the original on 17 April 2011.
- ^ Lima XT, Abuabara K, Kimball AB, Lima HC (August 2009). "Briakinumab". Expert Opinion on Biological Therapy. 9 (8): 1107–13. doi:10.1517/14712590903092188. PMID 19569977. S2CID 219184448.
- ^ "Abbott 2007 Annual Report: Pharmaceuticals". Abbott.com. Archived from the original on 2010-07-31. Retrieved 2010-05-12.
- ^ "MedImmune: External R&D Partnering". Archived from the original on 2013-04-28. Retrieved 2010-11-21.
- ^ Clinical trial number NCT00570986 for "A Study Comparing the Safety and Efficacy of Two Dosing Regimens of ABT-874 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis" at ClinicalTrials.gov
- ^ Clinical trial number NCT00691964 for "Study Comparing the Efficacy and Safety of ABT-874 to Etanercept and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis" at ClinicalTrials.gov
- ^ Clinical trial number NCT00086671 for "Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS)" at ClinicalTrials.gov
- ^ Clinical trial number NCT00562887 for "Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease" at ClinicalTrials.gov
- ^ Abbott Press Release: Abbott Reports Psoriasis Phase III Results of its Investigational IL-12/23 Inhibitor Briakinumab (ABT-874) Archived November 24, 2010, at the Wayback Machine
- ^ "The Free Library: Cambridge Antibody Technology and Abbott Agree Regarding Royalties". Archived from the original on 2012-10-21. Retrieved 2010-11-21.