Treats relapsing forms of multiple sclerosis (MS). BLA 125326, held by Novartis. Ofatumumab.
As of Nov 13, 2026, BLA 125326 (Arzerra, Kesimpta), held by Novartis, was first approved by FDA on Oct 26, 2009, with 12 approved supplements and 0 published complete response letters.
KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2020 | Supplement 70Efficacy (new indication or use) · Priority review | Approved | |
| Aug 30, 2016 | Supplement 63Efficacy (new indication or use) · Priority review | Approved | |
| Jan 19, 2016 | Supplement 62Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2014 | Supplement 60Efficacy (new indication or use) · Priority review | Approved | |
| Oct 26, 2009 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Arzerra100MG/5ML · injectable; injection | Ofatumumab | Rx |
| Kesimpta20MG/0.4ML · solution;subcutaneous | Ofatumumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 1, 2026 | Supplement 84Labeling · Standard review | Approved | |
| Aug 18, 2025 | Supplement 83Labeling · Standard review | Approved | |
| Apr 12, 2024 | Supplement 79Labeling · Standard review | Approved | |
| Jan 19, 2024 | Supplement 80Labeling · Standard review | Approved | |
| Sep 2, 2022 | Supplement 75Labeling · Standard review | Approved | |
| Aug 20, 2020 | Supplement 70Efficacy (new indication or use) · Priority review | Approved | |
| Aug 30, 2016 | Supplement 63Efficacy (new indication or use) · Priority review | Approved | |
| Jan 19, 2016 | Supplement 62Efficacy (new indication or use) · Priority review | Approved | |
| Apr 17, 2014 | Supplement 60Efficacy (new indication or use) · Priority review | Approved | |
| Sep 24, 2013 | Supplement 59Labeling · Standard review | Approved | |
| Sep 20, 2011 | Supplement 32Labeling · Standard review | Approved | |
| Sep 23, 2010 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 26, 2009 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
