FDA Grants Fast Track Status To Teva’s Emrusolmin, Advancing Development For Rare Neurodegenerative Disorder Multiple System Atrophy

Teva Pharmaceuticals, the U.S. affiliate of Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational therapy emrusolmin (TEV-56286) for the treatment of Multiple System Atrophy (MSA). Emrusolmin, which is being developed through a strategic collaboration with German biotech company MODAG GmbH, is currently under evaluation in a Phase 2 clinical trial to study its safety and effectiveness. The therapy had previously received Orphan Drug designation from the FDA for MSA in 2022.

Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva, stated, “Multiple System Atrophy is a devastating and rapidly progressive neurodegenerative disorder with no cure. The promising potential of emrusolmin is a testament to what we are building at Teva – a pipeline that truly meets patients’ needs and strategic partnerships that drive innovation.”

Dr. Matthias, CEO of MODAG, mentioned, "We are pleased to announce this next step in our collaboration with Teva, an organization that has longstanding expertise in the development of neuroscience therapeutics. This Fast Track Designation further underscores the potential of our therapeutic candidate to help patients living with MSA.”

Fast Track designation is intended to accelerate the development and review of treatments that address serious conditions with significant unmet medical needs. MSA is a rare and progressive neurodegenerative disorder that leads to severe motor and autonomic dysfunction and currently has no approved curative therapies. Treatment approaches today focus mainly on managing symptoms. Teva emphasized that this designation underscores both the urgency of advancing new therapies for patients with MSA and the company’s broader commitment to developing innovative treatments for neurological diseases.