FDA approves brodalumab for moderate-to-severe plaque psoriasis

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  • The U.S. Food and Drug Administration has just approved brodalumab (Siliq) for adults with moderate-to-severe plaque psoriasis.
  • Brodalumab is given via injection.
  • Brodalumab is intended for patients who have failed to respond or have stopped responding to other systemic therapies.
Why this matters
  • Some patients do not respond or stop responding to currently available therapies.
  • Brodalumab's approval is based on 3 randomized, placebo-controlled clinical trials including 4373 adult participants.
  • More patients treated with brodalumab achieved clear or almost clear skin compared with a placebo group.
  • Study results found an elevated risk for suicidal ideation and behavior with brodalumab.
  • The drug's labeling includes a Boxed Warning, and the drug is only available t...