Yes, Kesimpta Treats Relapsing Forms of Multiple Sclerosis
Kesimpta (ofatumumab) is an FDA-approved monoclonal antibody for adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. It targets CD20-positive B cells to reduce relapse rates and slow disability progression.[1]
How Kesimpta Works for MS
Kesimpta binds to B cells, depleting them via antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. In phase 3 trials like ASCLEPIOS I and II, it cut annualized relapse rates by 50-59% versus Aubagio (teriflunomide), with similar MRI lesion reductions and slower disability progression.[1][2]
Who Makes Kesimpta and When Was It Approved
Novartis manufactures Kesimpta. The FDA approved it in August 2020 for RMS, following European approval in 2020. It's self-administered monthly via subcutaneous injection after initial doses.[1]
How Does Kesimpta Compare to Other MS Drugs
| Drug | Dosing | Key Trial Relapse Reduction vs. Active Comparator | Common Side Effects |
|------|--------|--------------------------------------------------|---------------------|
| Kesimpta | Monthly subQ | 50-59% vs. Aubagio [2] | Injection reactions (20%), infections (51%), headache |
| Ocrevus (ocrelizumab) | Every 6 months IV | 46-47% vs. interferon [3] | Infusion reactions, infections |
| Briumvi (ublituximab) | Every 24 weeks IV | 59-62% vs. teriflunomide [4] | Infusion reactions, infections |
| Mavenclad (cladribine) | Oral, 2-year course | 47% vs. Rebif [5] | Lymphopenia, infections |
Kesimpta offers easier at-home dosing than IV options like Ocrevus but requires monitoring for infections and hepatitis B reactivation.[1]
Common Side Effects and Patient Concerns
Upper respiratory infections affect over half of users; injection-site reactions hit 20%. Rare risks include progressive multifocal leukoencephalopathy. Liver enzyme elevations occur in 10%; avoid in active hepatitis.[1] Patients often ask about pregnancy safety (Category not assigned; use contraception) and vaccination timing (delay live vaccines).[2]
Cost and Access
List price is about $6,500 per monthly dose, or $78,000 yearly, though copay cards reduce out-of-pocket to $0-5 for eligible patients. Medicare coverage is standard post-approval.[6]
Patent Status and Biosimilar Timeline
Novartis holds U.S. patents on Kesimpta until at least 2032 (composition of matter) and 2035 (formulation), with challenges ongoing. No biosimilars are approved; generics unlikely before 2032.[7]
[1]: FDA Label - https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761033s000lbl.pdf
[2]: Lancet Neurology (ASCLEPIOS trials) - https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(20)30419-6/fulltext
[3]: NEJM (OPERA trials for Ocrevus) - https://www.nejm.org/doi/full/10.1056/NEJMoa1601277
[4]: NEJM (ULTIMATE trials for Briumvi) - https://www.nejm.org/doi/full/10.1056/NEJMoa2307356
[5]: NEJM (CLARITY trials for Mavenclad) - https://www.nejm.org/doi/full/10.1056/NEJMoa1501464
[6]: Novartis Pricing - https://www.kesimpta.com
[7]: DrugPatentWatch.com - https://www.drugpatentwatch.com/p/tradename/KESIMPTA