Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

August 21, 2020 Auto Bot approval, Biotech, FDA, First, multiple sclerosis, Novartis, receives, regulatory 0

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

Click here ­to­ read full press release/ article | Ref: Novartis | Image: KRCU