FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Siliq (brodalumab)


Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.


Monoclonal antibody IgG2 antibody that targets interleukin-17RA and inhibits its interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F heterodimer, and IL-25.


210 mg SC at weeks 0, 1, and 2, THEN 210 mg SC q2wk.

If an adequate response has not been achieved after 12-16 weeks, consider discontinuing therapy; continued treatment beyond 16 weeks in patients who have not achieved an adequate response is not likely to result in greater success.


Approval was based on data from the AMAGINE phase 3 pivotal studies. The results highlighted that, at the 210-mg dose, brodalumab was shown to be effective in total skin clearance of psoriasis, compared to placebo, and superior to ustekinumab at week 12 in 2 replicate comparator trials involving over 3,500 patients.


Lebwohl M, et al. Phase 3 studies comparing brodalumab with ustekinumab in psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28.


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