Novartis AG — Kesimpta FDA Review (BLA125326, SUPPL 70, 2020)
Novartis AG · 2020 · FDA Review (openFDA) · company profile →
Report summary
Novartis's Kesimpta (ofatumumab) received FDA approval on August 20, 2020, for treating relapsing forms of multiple sclerosis (RMS) in adults. Administered subcutaneously, Kesimpta demonstrated superior efficacy over teriflunomide in two Phase 3 trials (G2301 and G2302), significantly reducing annualized relapse rates, 3-month confirmed disability progression, and MRI lesion activity. Key safety concerns include Progressive Multifocal Leukoencephalopathy (PML), injection-related reactions (mostly mild), and reductions in immunoglobulins, particularly IgM. Postmarketing requirements include a pregnancy exposure registry, pediatric assessments, and long-term immunoglobulin monitoring. Nonclinical studies identified potential risks like increased infection and fetal toxicity, leading to specific labeling requirements. The proprietary name "Kesimpta" was deemed acceptable, and human factors studies addressed potential medication errors.
Key findings — cited to the page
| Subjects with grade 3 leukocyte reduction (comparator) | 1 | COMB157G2302 · p.219 |
| Subjects with grade 3 leukocyte reduction | 0 | COMB157G2302 · p.219 |
| Subjects with grade 3 AST elevation | 1 | COMB157G2301 · p.217 |
| Subjects with grade 3 ALT elevation (comparator) | 1 | COMB157G2301 · p.217 |
| Subjects with grade 3 bilirubin elevation | 11 | COMB157G2301 · p.218 |
| Subjects with grade 3 bilirubin elevation (comparator) | 9 | COMB157G2301 · p.218 |
| Subjects with grade 4 neutrophil reduction | 3 | COMB157G2301 · p.217 |
| Subjects with grade 3 AST increase | 1 | COMB157G2302 · p.220 |
| Subjects with grade 4 neutrophil reduction (comparator) | 4 | COMB157G2301 · p.217 |
| Subjects with grade 3 ALT elevation | 1 | COMB157G2301 · p.217 |
| Subjects with grade 3 AST elevation (comparator) | 1 | COMB157G2301 · p.217 |
| Subjects with grade 4 neutrophil reduction | 2 | COMB157G2302 · p.220 |
Source: Novartis AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →