FDA Clears KORU FreedomEDGE System to Administer Rozanolixizumab-noli in gMG

The FDA cleared the KORU Medical FreedomEDGE infusion platform for the delivery of rozanolixizumab-noli (Rystiggo; UBC) in adults with generalized myasthenia gravis (gMG), expanding the device’s label to include administration of the Fc neonatal receptor (FcRn)–targeted therapy.1 This clearance may influence infusion and care setting logistics for gMG treatments.

This initiation of a healthcare provider–administered option complements existing frameworks for subcutaneous infusion technologies and potentially broadens sites of care beyond self-administration at home.1 FreedomEDGE is part of the Freedom Infusion System family, which supports large-volume subcutaneous infusions with flow rates and volumes ranging approximately from 5 mL to more than 50 mL. The platform has been in clinical practice for over 15 years with multiple on-label drugs and a high reported adherence rate in home settings, according to KORU, though detailed independent clinical evaluations of long-term outcomes for specific devices are limited.1

"Expanding from home administration into clinic-based care highlights the versatility of our Freedom Infusion System to deliver life-changing therapies wherever patients are treated. This clearance aligns with our strategy to extend the Freedom platform to more drug therapies, more settings, and more patients,” Linda Tharby, president and CEO at KORU Medical, said in a statement.1

Established Clinical Evidence for Rozanolixizumab in gMG

The 2023 FDA approval of the humanized IgG4 monoclonal antibody rozanolixizumab for gMG provided clinicians with an additional targeted therapeutic option,2 particularly for patients with anti-acetylcholine receptor (AChR) or anti–muscle-specific tyrosine kinase (MuSK) antibody positivity.1,3

Rozanolixizumab exerts its effect by binding the FcRn, thereby accelerating degradation of circulating IgG including pathogenic autoantibodies implicated in gMG pathophysiology.4,5

The pivotal phase 3 MycarinG trial (NCT03971422) served as the primary efficacy basis for FDA review.6 This multicenter, randomized, double-blind, placebo-controlled study enrolled adults with antibody-positive gMG and evaluated subcutaneous weekly infusions of rozanolixizumab versus placebo over a 6-week cycle. In the trial, patients treated with rozanolixizumab experienced statistically significant improvements in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at day 43 compared with placebo, a change generally interpreted as clinically meaningful in gMG evaluation.⁷

Secondary measures, such as quantitative myasthenia gravis (QMG) score changes, also favored the therapy, reinforcing the functional benefit observed in activities like breathing, swallowing, and mobility.6 Although, detailed long-term outcome data beyond the initial treatment cycle and real-world durability of responses remain areas for further study.

Key Safety Recommendations for Rozanolixizumab

Based on the FDA labeling and indications for rozanolixizumab, clinicians must consider immunosuppressive risks such as increased susceptibility to infections and potential infusion site administration-related reactions. In the MycarinG study and subsequent safety assessments, common adverse events included headache, infections, diarrhea, fever, hypersensitivity reactions, and nausea. Serious infections were observed in 4% of the study population.⁶

The FDA recommends avoiding immunization with live-attenuated or live vaccines during treatment with rozanolixizumab because of its effect on transient IgG levels. The evaluation of need for age-appropriate immunizations according to immunization guidelines is recommended prior to beginning a new treatment cycle.

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REFERENCES
1. KORU Medical announces FDA clearance for FreedomEDGE infusion system delivering RYSTIGGO. News release. KORU Medical. January 29, 2026. Accessed January 30, 2026. https://www.businesswire.com/news/home/20260129815700/en/KORU-Medical-Systems-Receives-FDA-510k-Clearance-for-Delivery-of-RYSTIGGO-rozanolixizumab-noli-Expanding-Label-for-FreedomEDGE-Infusion-System
2. UCB announces US FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalized myasthenia gravis. News release. June 27, 2023. Accessed January 30, 2026. https://www.prnewswire.com/news-releases/ucb-announces-us-fda-approval-of-rystiggo-rozanolixizumab-noli-for-the-treatment-of-adults-with-generalized-myasthenia-gravis-301864023.html
3. FDA Drug Trials Snapshot: RYSTIGGO. FDA. Updated May 9, 2024. Accessed January 30, 2026. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-rystiggo
4. RYSTIGGO. FDA Label. Revised June 2023. Accessed January 30, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761286s000lbl.pdf
5. RYSTIGGO: Efficacy. Rystiggo product website. Accessed January 30, 2026. https://www.rystiggohcp.com/clinical-trial
6. Bril V, Drużdż A, Grosskreutz J, et al. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023;22(5):383-394. doi:10.1016/S1474-4422(23)00077-7 
7. Myasthenia Gravis. Muscular Dystrophy Association. Updated May 2025. Accessed January 30, 2026. https://www.mda.org/sites/default/files/2023/09/MG-Fact-Sheet.pdf