Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Teva’s investigational therapy emrusolmin (TEV-56286) for the treatment of Multiple System Atrophy (MSA).

Emrusolmin is part of a strategic collaboration with MODAG GmbH, a privately held German biotech company, and is currently being evaluated in a Phase 2 trial to assess its efficacy and safety. The U.S. FDA granted Orphan Drug designation to emrusolmin for MSA in 2022.

“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.”

Fast Track Designation is a U.S. FDA process designed to facilitate the development and expedite the review of new drugs with the potential to treat serious conditions and address 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.”