This section highlights FDA-related milestones and regulatory updates for drugs developed by Viatris (VTRS).
Over the past two years, Viatris has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Cenerimod, EFFEXOR, meloxicam, and XULANE. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Cenerimod - FDA Regulatory Timeline and Events
Cenerimod is a drug developed by Viatris for the following indication: In Lancet Rheumatology.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Cenerimod
- Announced Date:
- December 18, 2024
- Indication:
- In Lancet Rheumatology
Announcement
Viatris Inc. announced the publication of Phase 2b CARE study results evaluating the efficacy and safety of cenerimod in adults with moderate-to-severe systemic lupus erythematosus (SLE).
AI Summary
Viatris Inc. announced the publication of Phase 2b CARE study results showing that cenerimod, an investigational S1P1 receptor modulator, is effective and safe for adults with moderate-to-severe systemic lupus erythematosus (SLE). In the study, patients receiving a 4 mg dose of cenerimod experienced significant and sustained improvements in SLE symptoms compared to those on placebo, all while continuing their standard SLE therapies.
Additionally, biomarker data published in the Annals of the Rheumatic Diseases further clarified cenerimod’s mechanism of action. The analysis demonstrated that cenerimod works by lowering IFN-related proteins and gene expressions, confirming its multifaceted immunomodulatory effects. The trial also showed that cenerimod is generally well tolerated, supporting the decision to move forward with further Phase 3 studies.
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EFFEXOR - FDA Regulatory Timeline and Events
EFFEXOR is a drug developed by Viatris for the following indication: In adults with generalized anxiety disorder (GAD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EFFEXOR
- Announced Date:
- April 21, 2025
- Indication:
- In adults with generalized anxiety disorder (GAD).
Announcement
Viatris Inc. announced it has filed applications to the Ministry of Health, Labor and Welfare (MHLW) for approval of Effexor SR Capsules (venlafaxine hydrochloride), a serotonin-noradrenaline reuptake inhibitor (SNRI) to treat adults with generalized anxiety disorder (GAD), an indication for which no other treatment option is currently approved in Japan.
AI Summary
Viatris Inc. has filed applications with Japan’s Ministry of Health, Labor and Welfare (MHLW) seeking approval for Effexor SR Capsules (venlafaxine hydrochloride) to treat adults with generalized anxiety disorder (GAD). This filing targets a significant gap in Japan, where there is currently no approved treatment option for GAD. The application is backed by positive results from a Phase 3, placebo-controlled study conducted in Japan, where Effexor showed superior anxiolytic effects compared to placebo and met all secondary endpoints. Effexor, a serotonin-noradrenaline reuptake inhibitor (SNRI), is already approved in Japan for major depressive disorder and is used to treat GAD in more than 80 other countries. The efforts by Viatris aim to address the needs of patients who suffer from chronic, uncontrollable anxiety that affects their everyday activities and overall quality of life.
Read Announcement- Drug:
- EFFEXOR
- Announced Date:
- October 9, 2024
- Indication:
- In adults with generalized anxiety disorder (GAD).
Announcement
Viatris Inc. announced positive top-line results of its Phase 3 study (B2411367) in Japan evaluating the safety and efficacy of EFFEXOR® (venlafaxine) in adults with generalized anxiety disorder (GAD).
AI Summary
Viatris Inc. announced positive top-line results from its Phase 3 study (B2411367) in Japan, evaluating the safety and efficacy of EFFEXOR® (venlafaxine) for treating generalized anxiety disorder (GAD) in adults. The study met its primary objective by demonstrating superior anxiolytic effects compared to a placebo after 8 weeks, using the Hamilton Anxiety Rating Scale (HAM-A) as the key measurement. All seven secondary endpoints were also achieved, further supporting the efficacy of EFFEXOR® in reducing both psychic and somatic anxiety factors.
The treatment was generally well tolerated and its safety profile was consistent with previous studies in non-Japanese patients. With low rates of treatment discontinuation and a reduced incidence of new suicidal ideation compared to placebo, these results highlight the potential of EFFEXOR® as a promising treatment option for a significant unmet need in Japanese patients with GAD.
Read Announcement- Drug:
- EFFEXOR
- Announced Date:
- October 9, 2024
- Indication:
- In adults with generalized anxiety disorder (GAD).
Announcement
Viatris Inc. announced that Pharmaceuticals and Medical Devices Agency (PMDA) submission targeted for 2025
AI Summary
Viatris Inc. announced that it is aiming to submit its application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for EFFEXOR® in 2025. This submission is a key step in bringing a treatment option for generalized anxiety disorder (GAD) to a market with a significant unmet need, as there are currently no approved therapies for this condition in Japan. The decision follows positive top-line results from a Phase 3 study conducted in Japanese patients, where EFFEXOR® not only met its primary endpoint by showing significant superiority over placebo on the Hamilton Anxiety Rating Scale but also achieved all secondary efficacy endpoints. The study further confirmed that EFFEXOR® is generally well tolerated, with a safety profile consistent with its known use in non-Japanese patients.
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meloxicam - FDA Regulatory Timeline and Events
meloxicam is a drug developed by Viatris for the following indication: For the Treatment of Moderate-to-Severe Acute Pain.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- meloxicam
- Announced Date:
- May 8, 2025
- Indication:
- For the Treatment of Moderate-to-Severe Acute Pain
Announcement
Viatris Inc announced positive results from its Phase 3 program of the novel fast-acting formulation of meloxicam (MR-107A-02) for the treatment of moderate-to-severe acute pain.
AI Summary
Viatris Inc. announced positive results from its Phase 3 study of a novel fast-acting meloxicam formulation (MR-107A-02) designed to treat moderate-to-severe acute pain. The study demonstrated that this innovative formulation delivers rapid pain relief, meeting key efficacy and safety endpoints. Researchers found that the product’s fast-acting properties may significantly improve patient outcomes by providing effective pain management in acute settings. Additionally, the favorable safety profile observed in the trial suggests that MR-107A-02 could become an important option for patients who need swift and reliable relief without compromising tolerability.
The promising Phase 3 results support Viatris’ commitment to addressing critical needs in pain management. The company looks forward to engaging with the FDA as it advances this breakthrough treatment toward potential approval, which could offer a valuable new therapy for those suffering from acute pain.
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XULANE LO - FDA Regulatory Timeline and Events
XULANE LO is a drug developed by Viatris for the following indication: For Birth Control in Women of Childbearing Potential.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XULANE LO
- Announced Date:
- May 8, 2025
- Indication:
- For Birth Control in Women of Childbearing Potential
Announcement
Viatris Inc. announced positive results of its Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and safety of investigational XULANE LO low dose weekly dermal patch of 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day in women of childbearing potential.
AI Summary
Viatris Inc. announced positive Phase 3 results for its investigational XULANE LO low dose weekly dermal patch. The study (NCT05139121) evaluated the contraceptive efficacy and safety of the patch, which releases 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day, in women of childbearing potential. With a Pearl Index of 4.14 and a cumulative pregnancy probability of 3.7% over 13 cycles, the patch showed effective contraceptive performance while maintaining a favorable safety profile. Most treatment-emergent side effects were reported as mild-to-moderate, and there were very few incidents of patch detachment or severe local reactions.
Viatris is encouraged by these results, noting the patch’s potential best-in-class adhesion and cycle control. The company plans to submit a New Drug Application to the U.S. FDA in the second half of 2025, reinforcing its commitment to providing women a reliable, reversible birth control method with a lower estrogen dose.
Read Announcement
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