Viatris Advances Innovative Portfolio with Approval of Effexor® in Japan for Adults with Generalized Anxiety Disorder (GAD)

Viatris (Nasdaq: VTRS) announced MHLW approval of Effexor SR 37.5 mg / 75 mg for adults with generalized anxiety disorder (GAD) in Japan on March 23, 2026.

Rhea-AI Summary

Viatris (Nasdaq: VTRS) announced MHLW approval of Effexor SR 37.5 mg / 75 mg for adults with generalized anxiety disorder (GAD) in Japan on March 23, 2026.

This makes Effexor the first and only approved GAD treatment in Japan; approval is supported by a Phase 3 trial (p=0.012) and long-term extension data.

Positive

• First approved GAD therapy in Japan
• Phase 3 primary endpoint met (two-sided p=0.012)
• Effexor already approved for GAD in 80+ countries

Negative

• Higher discontinuation with treatment: 7.3% vs 1.7% (placebo)
• Treatment-related discontinuations: 3.9% vs 0.6% (placebo)

Argus Mar 23 session

+0.68% close to close Open Argus

Details

News Market Reaction – VTRS

On Mar 23, the day this news came out, VTRS closed 0.68% above the previous close.

Data tracked by StockTitan Argus for the Mar 23 session.

Market Context

This announcement highlights Japan’s approval of Effexor SR for adults with GAD, the country’s first...

Analysis

This announcement highlights Japan’s approval of Effexor SR for adults with GAD, the country’s first approved treatment option for this condition, supported by a Phase 3 study that met its primary endpoint with a HAM-A p-value of 0.012. All seven secondary endpoints were achieved and safety was consistent with prior experience. In the context of Viatris’ recent strategic growth and regulatory milestones, investors may watch how this new indication contributes to its broader CNS and international portfolio over time.

Key Figures

Effexor SR dose: 37.5 mg Effexor SR dose: 75 mg GAD prevalence: 7.6% +5 more

Effexor SR dose

37.5 mg

Capsule strength approved for GAD in Japan

Effexor SR dose

75 mg

Capsule strength approved for GAD in Japan

GAD prevalence

7.6%

Prevalence of probable GAD in Japan general population

Primary endpoint p-value

p=0.012

HAM-A total score change at 8 weeks vs placebo

TEAE discontinuation rate

7.3% vs 1.7%

Treatment-emergent AE-related discontinuations vs placebo

Treatment-related TEAEs

3.9% vs 0.6%

Adverse events assessed as related to treatment vs placebo

Serious TEAEs

0% vs 1.1%

Serious treatment-emergent adverse events vs placebo

Severe-intensity TEAEs

0% vs 0.6%

Severe-intensity treatment-emergent adverse events vs placebo

Historical Context

5 past events · Latest: Mar 19

5 events

1. Mar 19

   Long-term growth plan

   24h Move

   -1.8%

   Outlined 2030 revenue, EBITDA and EPS CAGR targets with cash deployment plans.

2. Feb 26

   Q4/FY2025 earnings

   24h Move

   -5.2%

   Reported FY2025 results with GAAP net loss from goodwill impairment and workforce cuts.

3. Feb 26

   Dividend policy

   24h Move

   -5.2%

   Maintained 2026 dividend policy and declared quarterly dividend to shareholders.

4. Feb 25

   Regulatory sNDA update

   24h Move

   +0.1%

   FDA accepted sNDA for MR-141 for presbyopia with positive Phase 3 data supporting.

5. Feb 03

   Earnings date set

   24h Move

   +5.0%

   Announced Q4/FY2025 earnings date and an upcoming investor event in New York.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

serotonin-noradrenaline reuptake inhibitor, snri, generalized anxiety disorder, phase 3, +4 more

8 terms

serotonin-noradrenaline reuptake inhibitor medical

"venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI), for the"

A serotonin-noradrenaline reuptake inhibitor is a class of medication that raises levels of two brain chemicals—serotonin and noradrenaline—by blocking their removal from the spaces between nerve cells, similar to keeping more water in a sink by partially closing the drain. Investors care because these drugs target common conditions such as depression and pain, so their safety profile, clinical trial results, regulatory approvals, patent life and market competition directly affect sales prospects and company valuation.

snri medical

"venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI), for the"

A serotonin-norepinephrine reuptake inhibitor (SNRI) is a class of prescription medicines that raise levels of two brain chemicals, serotonin and norepinephrine, by preventing the brain from quickly reabsorbing them; think of it as keeping more of two mood-related signals circulating like turning up a thermostat. Investors watch SNRIs because their effectiveness, side-effect profile, patent status and regulatory reviews directly affect a drug’s sales potential, development costs and market value, similar to how product reliability and demand shape a company’s revenue prospects.

generalized anxiety disorder medical

"approved Effexor SR 37.5 mg / 75 mg capsules ... for the treatment of adults with generalized anxiety disorder"

Generalized anxiety disorder is a chronic mental health condition marked by persistent, excessive worry about everyday things that is hard to control and interferes with daily life. Think of it like a smoke alarm that stays on for weeks or months, making work, decision-making and productivity harder; for investors it matters because it drives demand for treatments, affects workforce performance and can influence regulatory scrutiny, clinical trial design and healthcare spending.

phase 3 medical

"based on a Phase 3 placebo-controlled, randomized, double-blind, multicenter study"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

placebo-controlled medical

"based on a Phase 3 placebo-controlled, randomized, double-blind, multicenter study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

double-blind medical

"Phase 3 placebo-controlled, randomized, double-blind, multicenter study of venlafaxine"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

hamilton anxiety rating scale medical

"based on the change in the Hamilton Anxiety Rating Scale (HAM-A) total score"

A clinician-administered questionnaire that measures the severity of a person's anxiety symptoms by scoring signs like tension, worry, and sleep trouble; think of it as a thermometer or ruler for anxiety used by doctors in clinical trials. Investors watch changes in this score because drug candidates that produce meaningful declines on the scale can drive regulatory approval, prescribing decisions, and market value, while weak or mixed results can hurt a company's prospects.

treatment emergent adverse events medical

"Low discontinuation rates due to treatment emergent adverse events (TEAEs) were seen"

Treatment emergent adverse events are any new or worsened medical problems that appear after a patient starts a drug or medical intervention during a clinical trial. Investors care because the number, severity, and frequency of these events influence safety profiles, regulatory approval chances, and market acceptance; think of them like unexpected problems that crop up after installing a software update—minor ones may be manageable, but serious or common issues can stall or derail the product.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Addresses a Significant Unmet Need in Japan as First and Only Approved Treatment Option for GAD

PITTSBURGH, March 23, 2026 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Effexor^® SR 37.5 mg / 75 mg capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI), for the treatment of adults with generalized anxiety disorder (GAD). Following the MHLW's decision, Effexor^® becomes the first and only approved treatment option in Japan for adults living with GAD, addressing a long-standing unmet medical need in mental health and enabling new access to care. Effexor^® is currently approved in Japan for the indication of major depressive disorder in adults, and with this approval, is now available to patients with GAD.

GAD is among the most prevalent and highly disabling mental health conditions, negatively impacting patients' quality of life and disrupting activities of daily living. A recent study reported the prevalence of probable GAD in Japan as 7.6% of the general population.¹

"The approval of Effexor^® in Japan for generalized anxiety disorder demonstrates the successful execution of our strategy to advance a differentiated and increasingly innovative portfolio in Japan, bringing forward value-added therapies that address a significant unmet need," said Philippe Martin, Viatris Chief R&D Officer. "This approval also reflects our ability to effectively implement an optimized lifecycle strategy for our established brands and to leverage our deep local expertise."

"This approval marks the introduction of a new treatment option for adults in Japan living with GAD," said Corinne Le Goff, Viatris Chief Commercial Officer. "We look forward to leveraging our strong infrastructure and deep expertise in central nervous system therapies in Japan to bring access to this much needed treatment to patients."

The approval of Effexor^® for GAD is based on a Phase 3 placebo-controlled, randomized, double-blind, multicenter study of venlafaxine in patients with GAD conducted in Japan (Study B2411367), which achieved its primary objective of superiority of anxiolytic effects of venlafaxine compared to placebo at 8 weeks, based on the change in the Hamilton Anxiety Rating Scale (HAM-A) total score from baseline (two-sided p-value=0.012). All seven secondary efficacy endpoints as defined by the trial protocol were met. Effexor^® was generally well tolerated with a profile consistent with its known safety profile in non-Japanese patients. In particular:

• Low discontinuation rates due to treatment emergent adverse events (TEAEs) were seen (7.3% vs 1.7% in placebo) with 3.9% vs 0.6% assessed as related to treatment.
• No serious TEAEs or TEAEs with severe intensity were observed (0% vs 1.1% and 0.6%, respectively, in placebo).

These results and the results of a long-term extension study of venlafaxine in Japanese outpatients with GAD were included as part of the applications for approval. Effexor^® is currently approved to treat GAD in more than 80 countries outside of Japan.

About Generalized Anxiety Disorder (GAD) 
Generalized Anxiety Disorder (GAD) is a mental health disorder whose central symptom is chronic and uncontrollable "anxiety" or "worry" about everyday life events or activities. Other symptoms include difficulty to get enough sleep, muscle tension/stiffness, feeling restless, irritable, or finding it difficult to concentrate, which may cause impairment in social, occupational, or other areas of functioning. In Japan, the World Health Organization reports that 2.6% of the population will suffer from GAD in their lifetime. A recent study in Japan reported the prevalence of probable GAD is 7.6%¹, suggesting that this condition may be significantly underdiagnosed.

About Viatris' Innovative Portfolio in Japan
Viatris' portfolio of innovative products in Japan includes approved products such as Spydia^® Nasal Spray (diazepam) for the treatment of status epilepticus. The company's pipeline in Japan includes investigational products such as pitolisant for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea syndrome and narcolepsy, and products in pivotal Phase 3 trials which are currently ongoing, such as selatogrel in acute myocardial infarction (AMI), Nefecon in IgA nephropathy, and cenerimod in systemic lupus erythematosus (SLE).

About Viatris 
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company whose mission is to empower people worldwide to live healthier at every stage of life. We meet the needs of patients around the world by acting decisively with ingenuity and resolve. Whether we're developing new medicines, working to maintain a resilient supply of needed therapies, or pursuing bold innovation, we deliver solutions that are effective at scale and built to endure. We're purpose-built to make an impact with a dynamic portfolio that spans generics, established brands and innovative medicines that address areas of significant unmet need. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai, China, and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

References:

1. Matsuyama S, Otsubo T, Nomoto K, Higa S, Takashio O. Prevalence of Generalized Anxiety Disorder in Japan: A General Population Survey. Neuropsychiatr Dis Treat. 2024;20:1355-1366.

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 advances innovative portfolio with approval of Effexor^® in Japan for adults with GAD; addresses a significant unmet need in Japan as first and only approved treatment option for GAD; the approval of Effexor^® in Japan for generalized anxiety disorder demonstrates the successful execution of our strategy to advance a differentiated and increasingly innovative portfolio in Japan, bringing forward value-added therapies that address a significant unmet need; this approval also reflects our ability to effectively implement an optimized life cycle strategy for our established brands and leverage our deep local expertise; we look forward to leveraging our strong infrastructure and deep expertise in central nervous system therapies in Japan to bring access to this much needed treatment to patients; 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; failure to achieve the intended benefits of our strategic initiatives and priorities; goodwill or impairment charges or other losses; any changes in or difficulties with the Company's manufacturing facilities; failure to achieve expected or targeted future financial and operating performance and results; Viatris' or its partners' ability to develop, manufacture, and commercialize products; 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; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; any significant breach of data security or data privacy or disruptions to our IT systems; 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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SOURCE Viatris Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Viatris (VTRS) announce about Effexor approval in Japan on March 23, 2026?

Viatris announced MHLW approval of Effexor SR for adults with GAD in Japan, making it the first approved option. According to the company, the decision follows positive Phase 3 and extension study data supporting efficacy and tolerability.

What were the key Phase 3 results supporting Effexor approval for GAD in Japan (Study B2411367)?

The Phase 3 study achieved its primary objective with superiority vs placebo at 8 weeks (two-sided p=0.012). According to the company, all seven secondary efficacy endpoints were also met and long-term extension results were included.

How well tolerated was Effexor in the Japanese GAD study for Viatris (VTRS)?

Effexor was generally well tolerated with no serious or severe TEAEs reported in the trial. According to the company, discontinuation rates were higher for treatment (7.3% vs 1.7%) with 3.9% assessed as treatment-related.

Does the Effexor approval expand access for GAD patients in Japan and when will it be available?

Yes; the approval introduces the first approved GAD therapy for adults in Japan, expanding treatment options. According to the company, Effexor is now available to patients with GAD following the MHLW decision on March 23, 2026.

What is the regulatory and commercial significance of Effexor approval for Viatris (VTRS) in Japan?

The approval advances Viatris' lifecycle strategy and CNS portfolio in Japan, adding a value-added therapy for GAD. According to the company, this leverages its local infrastructure to bring access to a long-standing unmet medical need.