FDA Grants Fast Track Status to Emrusolmin for MSA Treatment

Emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA), has been given Fast Track designation by the U.S. Food and Drug Administration (FDA), according to a statement released today by Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.Emrusolmin is presently undergoing evaluation in a Phase 2 trial to determine its safety and effectiveness as part of a strategic partnership with MODAG GmbH, a privately held German biotech business. In 2022, the U.S. FDA designated emrusolmin for MSA as an orphan drug.

“Multiple system atrophy is a devastating and rapidly progressive neurodegenerative disorder with no cure,” said Eric Hughes, MD, PhD, Executive Vice President, Global R&D, and Chief Medical Officer at Teva. “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.”

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The FDA's Fast Track Designation process was created to speed up the development and evaluation of novel medications that have the potential to treat serious illnesses and meet urgent unmet medical needs.

"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," said Dr. Matthias, CEO of MODAG. “This Fast Track Designation further underscores the potential of our therapeutic candidate to help patients living with MSA.”