Boehringer Ingelheim’s Spevigo Receives the US FDA’s Approval as the First Treatment Option for Generalized Pustular Psoriasis Flares
Shots:
- The approval was based on the P-II (EFFISAYIL) trial evaluating Spevigo vs PBO in 53 patients with GPP flares
- The 12wk. P-II (EFFISAYIL) trial results showed that patients experienced a GPP flare, 54% vs 6% of patients treated with Spevigo for IV use showed no visible pustules one week after receiving treatment, AEs were reported in 66% vs 56%, serious AEs (6%), 17% and 6% had infections after 1wk.
- Spesolimab is currently under review by other regulatory authorities & has received BTD in China, Taiwan, US. The therapy has also received priority review in China and the US; ODD in Australia, Korea, Switzerland, and the US; RPD & FTD in Taiwan for GPP flares
Ref: PRNewswire | Image: Boehringer Ingelheim
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