FDA BRIEF: Week of February 13, 2017

SILIQ (brodalumab) injection

Valeant Pharmaceuticals,  Bridgewater, NJ, USA

broda
fda

INDICATION: Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

UNMET NEED:

  • Psoriasis, an autoimmune disorder, causes  plaque psoriasis
  • Moderate-to-severe plaque psoriasis can cause significant skin irritation and discomfort for patients
  • Another treatment option

REG PATHWAY: BLA

  • Boxed Warning and Siliq Risk Evaluation and Mitigation Strategy (REMS) due to risk of suicidal ideation and behavior
  • Medication Guide to inform patients of the risk of suicidal ideation and behavior

MECHANISM OF ACTION: Human monoclonal IgG2 antibody that selectively binds to human IL-17RA and inhibits its interactions with cytokines inhibiting release of pro-inflammatory cytokines and chemokines

EFFICACY:

  • 3 multicenter, randomized, double-blind, controlled trials, n= 4373, SILIQ vs placebo, also vs ustekinumab in 2 studies, 12 weeks duration
  • Change from baseline two co-primary endpoints: 1) At least 75% reduction in Psoriasis Area and Severity Index (PASI) fro baseline  and 2) proportion of subjects with static Physician’s Global Assessment (sPGA) of 0 (clear) or 1 (almost clear), and at least a 2-point improvement from baseline
  • Greater proportion of SILIQ subjects achieved PASI score 0 or 1

SAFETY:

  • Suicidal ideation and behavior, including completed suicides
  • Most common adverse reactions: Arthralgia, headache, fatigue, diarrhea, throat pain (oropharyngeal pain), nausea, muscle pain (myalgia), injection site reactions, influenza, low white blood cell count (neutropenia) and fungal (tinea) infections

LABEL


 

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