Viatris Expands Innovative Portfolio in Cardiovascular Diseases with the Company's First Launch of Inpefa® (Sotagliflozin) for the Treatment of Heart Failure

Builds on Viatris' Scientific Leadership and Commercial Legacy in Cardiovascular Diseases

PITTSBURGH, Jan. 20, 2026 /PRNewswire/ -- Viatris Inc. (NASDAQ:VTRS), a global healthcare company, today announced the launch of Inpefa^® (sotagliflozin) in the United Arab Emirates (UAE), the first country within the Viatris territories to commercialize the treatment. Future launches are planned in multiple countries over the next several years, supporting Viatris' strategy to expand access to the treatment in key markets outside of the U.S. and Europe.

Inpefa is the first and only dual SGLT1/2 inhibitor approved for the treatment of heart failure. The treatment is approved in the U.S. and UAE to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

"The launch of Inpefa in the UAE marks another important step as we continue to deliver innovative medicines for patients around the world," said Corinne Le Goff, Viatris Chief Commercial Officer. "Heart failure is the world's leading cause of hospitalization, and as such there is an ongoing need for new treatments to help address this burden. This milestone also builds upon our robust legacy in cardiovascular diseases, reinforcing our commitment to expand the impact of Inpefa to help address the needs of patients around the world."

"Our success in extending the global reach of Inpefa is evidence of our growing innovative pipeline, which includes several late-stage programs that are advancing at a very strong pace," said Philippe Martin, Viatris Chief R&D Officer. "With its dual SGLT inhibition, Inpefa provides cardiologists with a unique therapeutic option that provides early benefit in reducing heart failure-related outcomes, potentially offering a meaningful role in reducing healthcare burden. We have already submitted regulatory filings across several countries, including Canada, Australia and Mexico, and will continue to broaden our global submissions over the coming years."

The approval of Inpefa is based on two pivotal Phase 3 trials—SOLOIST-WHF and SCORED—enrolling more than 11,800 patients globally and significantly reducing the risk of major cardiovascular events in high-risk populations. In SOLOIST-WHF, Inpefa reduced the composite risk of heart failure hospitalization, urgent visits, and cardiovascular death by 33% versus placebo in patients recently hospitalized for worsening heart failure, with benefits increasing up to 51% when initiated prior to discharge and evident within 30 days post-discharge. In SCORED, among patients with type 2 diabetes and chronic kidney disease with additional cardiovascular risk factors—both with and without heart failure—Inpefa achieved a 25% reduction in the same composite endpoint. Consistent with its dual SGLT1 and SGLT2 inhibition, MACE—defined as CV death, non-fatal MI, and non-fatal stroke—was reduced by 23%, with benefits observed as early as 94 days. It is the first SGLT inhibitor to show a significant reduction in both MI (32%) and stroke (34%).

About Heart Failure

Heart failure is the world's leading cause of hospitalization, affecting more than 64 million people worldwide. It is a serious condition that usually has no cure and occurs when the heart is not pumping as well as it should, hence compromising blood and oxygen supply to the tissues. It is estimated that one in every five people will develop heart failure during their lifetime. After hospital discharge, both mortality and readmission rates remain substantial worldwide. The 30-day post-discharge mortality is approximately 6.7%, and readmission rates average 13%, underscoring the ongoing risk during the vulnerable post-hospitalization period. At one year post-discharge mortality increases to an average 23%, and readmission rates increase to an average of 36%.

About Inpefa (sotagliflozin)

Sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is primarily responsible for absorbing glucose and sodium in the small intestine, as well as for reabsorbing a small amount of glucose in the kidney's distal tubule. SGLT1 is also found in the heart and vascular endothelium, where it may influence cellular stress and inflammatory pathways—suggesting roles beyond glucose control. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. It was approved by the by the U.S. Food and Drug Administration in May 2023 to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

Viatris and Lexicon Licensing Agreement

In October 2024, Viatris announced it had entered into an exclusive licensing agreement with Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) for sotagliflozin in all markets outside of the U.S. and Europe. Inpefa is marketed by Lexicon Pharmaceuticals in the U.S. 

About Viatris

Viatris Inc. (NASDAQ:VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter).

Forward-Looking Statements

This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements that Viatris expands innovative portfolio in cardiovascular diseases with the Company's first launch of Inpefa^® (Sotagliflozin) for the treatment of heart failure; builds on Viatris' scientific leadership and commercial legacy in cardiovascular diseases; launch of Inpefa^® (sotagliflozin) in the UAE, the first country within the Viatris territories to commercialize the treatment; future launches are planned in multiple countries over the next several years, supporting Viatris' strategy to expand access to the treatment in key markets outside of the U.S. and Europe; Inpefa is the first and only dual SGLT1/2 inhibitor approved for the treatment of heart failure; the launch of Inpefa in the UAE marks another important step as we continue to deliver innovative medicines for patients around the world; this milestone also builds upon our robust legacy in cardiovascular diseases, reinforcing our commitment to expand the impact of Inpefa to help address the needs of patients around the world; our success in extending the global reach of Inpefa is evidence of our growing innovative pipeline, which includes several late-stage programs that are advancing at a very strong pace; with its dual SGLT inhibition, Inpefa provides cardiologists with a unique therapeutic option that provides early benefit in reducing heart failure-related outcomes, potentially offering a meaningful role in reducing healthcare burden; we have already submitted regulatory filings across several countries, including Canada, Australia and Mexico, and will continue to broaden our global submissions over the coming years; and the outcome of clinical trials. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company's products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

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