Shots:

• The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg- monthly- SC) vs teriflunomide (14mg- qd) in 1-882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally- P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS
• ASCLEPIOS I & II studies results: reduction in ARR 51% & 59% (0.11 vs 0.22) & (0.10 vs 0.25)- 34% reduction in 3mos CDP- reduction in number of Gd+ T1 (98% & 94%) and new/ enlarging T2 lesions (82% & 85%) respectively
• In a post hoc analysis- Kesimpta may halt new disease activity in RMS with 47.0% & 7.8% of patients achieved (NEDA-3) within (0–12mos.) and (12–24 mos.) of treatment- respectively. The therapy is expected to be available in the US in early Sept’2020 along with its anticipated EU approval in Q2’21

­ Ref: Novartis | Image: Novartis