Teva’s Emrusolmin Granted U.S. FDA Fast Track Designation for Treatment of Multiple System Atrophy
- Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development.
- New therapeutic options for people living with MSA, a rare and devastating neurodegenerative disorder, are urgently needed as there are no treatments available that impact disease progression.
- Emrusolmin is a small molecule that targets the alpha synuclein protein, which is believed to be pivotally involved in the pathogenesis of MSA. The U.S. FDA granted Orphan Drug designation to emrusolmin for MSA in 2022.
PARSIPPANY, N.J., Sept. 09, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), 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.”
Building on a legacy of innovation in neuroscience, Teva is committed to bringing treatments forward to address significant unmet needs of people with neurological conditions. MSA steadily worsens over time, leading to severe motor and autonomic dysfunction. Today, there are no curative treatments for MSA, and management of the disease is primarily focused on symptom relief.
About Emrusolmin (TEV-56286)
Emrusolmin (TEV-56286) is an investigational therapy being developed for the treatment of Multiple System Atrophy (MSA) that targets pathological alpha-synuclein oligomers. It is currently being evaluated in a Phase 2 trial to assess its efficacy and safety in people living with MSA.
About Multiple System Atrophy (MSA)
MSA is a rare neurodegenerative disorder classified clinically as "atypical parkinsonism" and belongs to the group of synucleinopathies. MSA is characterized histopathologically by abnormal deposits of the α-synuclein protein, mainly in oligodendroglial cells (glial cytoplasmic inclusions) and also in certain nerve cells. Typically, there is a dysfunction of the autonomic nervous system, i.e., disturbances of bladder function, erectile function, intestinal mobility, or the regulation of blood pressure in combination with a movement disorder. The movement disorder often presents with either Parkinson-like symptoms or a disturbance of cerebellar function, such as ataxia, gait and speech problems. In the US, EU, and Japan, MSA affects about 40,000 people (prevalence of 4 per 100,000), with about 6,000 new cases diagnosed each year (incidence of 0.6 per 100,000). Post-diagnosis life expectancy is about 7-10 years. Due to the relatively small number of affected patients and lack of effective therapy, MSA qualifies for orphan status, allowing a shorter development path. This unmet medical need for MSA disease modification is the driver to develop new therapies that could potentially impact the lives of patients.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
About MODAG
MODAG, a privately held German biotech company, is focused on the research and development of therapeutics and diagnostics for neurodegenerative diseases. MODAG's innovative approach offers a unique combination of early diagnosis and targeted disease-modifying therapies for severe neurological disorders. MODAG's collaborations with the top-tier US and European research institutions, combined with its founders and management team's interdisciplinary research and development expertise, provide ideal conditions for accelerated implementation of clinical applications. Built upon an extensive portfolio of patented active compounds, MODAG is developing a new oligomer modulator for MSA, PD and other synucleinopathies such as Alzheimer's disease, intending to deliver novel, first-in-class drugs with the potential to halt disease progression. For more information, see www.modag.net.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize emrusolmin (TEV-56286) for the treatment of MSA; our ability to successfully compete in the marketplace, including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2025 and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned “Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquiries:
TevaIR@tevapharm.com
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
