Drug Approval | December 13, 2022
European Commission approves SPEVIGO for generalized pustular psoriasis flares
EC grants conditional marketing authorization based on the EFFISAYIL trial
EC grants conditional marketing authorization based on the EFFISAYIL trial
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
CHMP positive opinion is based on evidence from the EFFISAYIL trial, the largest clinical trial in
Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares
With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction
Boehringer Ingelheim continues to innovate to enhance the customer experience and improve animal health and well-being
Clinical improvements were consistent across patient subgroups including age, gender, ethnicity, and IL-36 gene mutation status
The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe
Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases
Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction
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