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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Tremfya (guselkumab)

Indication:

Adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Mechanism:

Human monoclonal IgG1-lambda antibody that selectively binds to the p19 subunit of IL-23, thereby inhibiting the proinflammatory actions of IL-23.

Dosage:

100 mg SC at week 0, week 4, and q8wk thereafter.

Approval:

Approval was based on three phase 3 studies (n>2000). The VOYAGE I and 2 trials compared guselkumab with adalimumab. At 16 weeks, at least 7 of 10 patients treated with guselkumab achieved at least 90% clearer skin (Psoriasis Area and Severity Index [PASI 90]), and more than 80% demonstrated cleared or almost cleared skin. Results were maintained at week 48. The drug also demonstrated effectiveness in patients who had an inadequate response to ustekinumab.

References:

Blauvelt A, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol. 2017 Mar;76(3):405-17.

Reich K, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017 Mar;76(3):418-31.

Langley RG, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: Results of the randomized, double-blind, Phase 3 NAVIGATE trial. Br J Dermatol. 2017 Jun 21.

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