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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Siliq (brodalumab)

Indication:

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.

Mechanism:

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.

Dosage:

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:

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.

Reference:

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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