Aurinia’s Lupkynis (voclosporin) Receives EC’s Approval for the Treatment of Lupus Nephritis
Shots:
- The EC has granted marketing authorization for Lupkynis in adults with active LN. The MHRA’s decision in Great Britain is expected in the coming weeks
- The EC’s decision was based on the P-III (AURORA 1 & 2) study to evaluate Lupkynis which showed that voclosporin + MMF & low-dose corticosteroids led to superior complete renal response rates @52wks. over MMF and low-dose corticosteroids alone. The safety profile was comparable to MMF & low-dose corticosteroids alone
- The centralized marketing authorization is valid in EU member states, Iceland, Liechtenstein, Norway & Northern Ireland. Under the agreement with Otsuka, Aurinia will receive a $30.0M EC approval-related milestones & is eligible to receive a regulatory & reimbursement milestone along with royalties
Ref: Aurinia | Image: Aurinia
Click here to read the full press release
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
