Briakinumab - Ozespa
BRAND NAME: Ozespa
GENERIC NAME: briakinumab
EXPERIMENTAL/INTERNAL COMPANY NAME: ABT-874 |
|
| DRUG USE (P OR PsA) | METHOD OF DELIVERY | DEVELOPING COMPANY/COMPANIES |
| Moderate to severe psoriasis | Subcutaneous injection | Abbott Labs |
Description and Comments
An eagerly-anticipated addition to the psoriasis treatment arsenal, briakinumab (ABT-874, Ozespa) is Abbott's IL-12/IL-23 inhibitor (like Centocor Ortho Biotech's Stelara [ustekinumab]). Briakinumab and Stelara both target the immune system in a way that is different from the TNF-alpha inhibitors that include Enbrel, Humira and Remicade.
In
Phase Three briakinumab trials announced in October 2010, vast majorities of patients receiving once-a-month injections under the skin achieved major skin clearance for up to the one-year duration of the longest trial. But some patients did experience serious side effects, and FDA concerns about this apparently precipitated a
decision by Abbott to withdraw its application to market briakinumab for psoriasis. The decision was made public on January 14, 2011.
Briakinumab (Ozespa) and Stelara both hold great promise, but as of yet have only been observed in a few thousand patients for a few years (or less). The TNF-alpha inhibitors have been used by more than one million patients for psoriasis, psoriatic arthritis, rheumatoid arthritis (RA), Crohn's disease, and others, in some patients for more than a decade. So there are greater unknowns with ABT-874 and even Stelara, which is now FDA-approved for psoriasis. Briakinumab (ABT-874) had hoped to receive FDA approval for psoriasis in 2011, but that could now be several years off, and even might not occur--only time will tell. Another ominous sign is that a study of briakinumab for Crohn's disease has been terminated.
While there may be questions about its safety, briakinumab's effectiveness is impressive. In head-to-head clinical trials, briakinumab beat methotrexate and Enbrel (etanercept) in the proportion of patients whose skin symptoms improved. See the October 2010 report, below, for more information.
Other News and Links
Abbott withdraws application to market briakinumab for psoriasis. January 2011.
Read our full report on
briakinumab's four pivotal Phase Three psoriasis trials, including two head-to-head trials vs. Enbrel and a head-to-head trial vs. methotrexate. Great effectiveness, but is the safety confirmed? October 2010.
Read initial results from
briakinumab's 12-week trial against Enbrel. July 2010.
Read about
ABT-874's
strong Phase Two results. May 2007.
