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Rystiggo | Image Credit: © UCB

The approval marks the second international approval for rozanolixizumab (Rystiggo; UCB Pharma) for generalized myasthenia gravis (gMG), behind the February EU approval of 2 self-administration approvals for the neonatal Fc receptor monoclonal antibody: an infusion pump and manual push with a syringe.

Rystiggo | Image Credit: © UCB

Rozanolixizumab is a high-affinity humanized immunoglobulin G4 monoclonal antibody and Fc receptor blocker approved to treat anti–acetylcholine receptor– and anti–muscle-specific kinase–positive generalized myasthenia gravis (gMG) in adult patients; administration is subcutaneous and takes approximately 15 minutes.

Myasthenia gravis diagnosis | Image Credit: ©syahrir-stock.adobe.com

Finding similar frequencies of positive acetylcholine receptor antibodies in patients with ocular and generalized myasthenia gravis (MG), a Danish research team posits that ocular disease is most likely a more moderate form of generalized MG—not a fully separate condition.

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