FDA approves Spevigo for generalized pustular psoriasis
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The FDA has approved Spevigo for the treatment of generalized pustular psoriasis, Boehringer Ingelheim announced in a press release.
Spevigo (spesolimab) is the first investigational drug to target the interleukin-36 pathway for generalized pustular psoriasis (GPP) flares.
“This important approval reflects our successful efforts to accelerate our research with the aim to bring innovative treatments faster to the people most in need,” Carinne Brouillon, PharmD, MBA, member of the board of managing directors at Boehringer Ingelheim, said in the release. “We recognize how devastating this rare skin disease can be for patients, their families and caregivers. GPP can be life-threatening and until today there have been no specific approved therapies for treating the devastating GPP flares. It makes me proud that with the approval of Spevigo we can now offer the first U.S. approved treatment option for those in need.”
Approval was based on data from the 12-week, phase 2 EFFISAYIL clinical trial in which patients with GPP received a single 900 mg intravenous dose of spesolimab or placebo.
In the treatment group, 54% of patients showed no visible pustules after 1 week, compared with 6% of those treated with placebo.
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