Shots:
- The approval was based on the clinical program including two P-III TULIP & P-II MUSE trials evaluated the efficacy and safety of Saphnelo vs PBO in 362 & 305 patients with SLE who are receiving standard therapy
- The results showed a reduction in overall disease activity across organ systems, including skin and joints, and achieved a sustained reduction in OCS across both groups
- Saphnelo marks the first regulatory approval for a type I IFN receptor antagonist in Japan & has approved in the US for the same indication. The therapy is under regulatory review for SLE in the EU & company plans for an additional P-III trial for LN, CLE & myositis
Click here to read full press release/ article | Ref: AstraZeneca | Image: Mint
The post AstraZeneca’s Saphnelo (anifrolumab) Receives MHLW’s Approval for the Treatment of Systemic Lupus Erythematosus first appeared on PharmaShots.
