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Merck's Cladribine Capsules Receive FDA Fast Track Designation for Rare Neuromuscular Disorder

- Merck's cladribine capsules have received FDA Fast Track designation for treating generalized Myasthenia Gravis, potentially becoming the first oral treatment for this rare autoimmune neuromuscular disorder. - The drug previously received Orphan Drug Designation and is currently being evaluated in the global Phase 3 MyClad trial involving 264 patients with gMG. - Cladribine targets B and T cells that produce harmful autoantibodies causing inflammation at the neuromuscular junction, offering a convenient oral regimen for patients. - Merck has established a patient council and collaborates with over 20 advocacy groups worldwide to ensure the clinical program meets patient needs.