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PITTSBURGH , Dec. 18, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS ), a global healthcare company, today announced four recent regulatory milestones spanning across all stages of its global pipeline:
"We are proud of these recent regulatory achievements, which culminate a year of significant R&D advancement in 2025," said Viatris Chief R&D Officer Philippe Martin . "These important milestones not only demonstrate the strength of our scientific and regulatory capabilities, but also our dedication to addressing areas of significant unmet medical need for patients. We look forward to continuing to work closely with health authorities around the world as we progress our pipeline in 2026 and beyond."
About Octreotide Acetate for Injectable Suspension Octreotide acetate for injectable suspension is a long-acting medication used to help manage the symptoms of certain rare conditions, including acromegaly (a disorder in adults that causes abnormal growth of bones, organs and tissues) and complications associated with specific cancerous tumors. It is the Company's first approved injectable using microsphere technology.
This approval marks the Company's fourth injectable FDA approval in 2025 – joining iron sucrose, paclitaxel and liposomal amphotericin B – underscoring the Company's ability to successfully navigate complex regulatory pathways and strategy to expand its generics portfolio with technically complex, high-value products.
About Low Dose Estrogen Weekly Patch for Contraception The investigational treatment is a once-weekly transdermal contraceptive patch being developed for women of childbearing potential with a BMI below 30 kg/m² who are appropriate candidates for combined hormonal contraception and who prefer a non-invasive, reversible option with a lower estrogen dose. The patch delivers approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol per day and is applied once weekly for three weeks, followed by a one-week patch-free period.
The planned 505(b)(2) NDA is supported by results from the Phase 3 Luminous Study, which demonstrated a favorable efficacy and safety profile and strong patch adhesion performance.
The patch represents the potential to meet an important unmet medical need for women seeking alternatives to regular estrogen dose and long-acting contraception treatments. This investigational treatment option builds upon the Company's established capability in transdermal drug delivery and represents a lifecycle advancement of the contraceptive patch Xulane ® (norelgestromin and ethinyl estradiol transdermal system) 150/35 mcg per day.
About MR-146 for Neurotrophic Keratopathy NK is a rare but potentially sight-threatening corneal disease, which impacts approximately 73,000 people in the United States. It is a degenerative disease that causes progressive damage to the cornea. The most common causes of the disease are viral infections (herpes simplex, varicella zoster [shingles]), diabetes, multiple sclerosis, chemical burns, dry eye disease and corneal surgeries.
MR-146 utilizes an ETF TM AAV gene therapy platform, a first-of-its-kind approach designed to be delivered directly to the lacrimal gland via a single injection, using non-replicating DNA delivery transporters for the production and delivery of human Nerve Growth Factor (hNGF) protein to the cornea via tears. NK is the first indication of many that could be treated with this platform.
About Pitolisant Pitolisant is a selective histamine H3 receptor antagonist/inverse agonist that modulates the brain's sleep–wake pathways.
The J-NDA application is supported by positive Phase 3 data in Japanese patients. The Phase 3 trial evaluated the effect of pitolisant in Japanese patients with OSAS who were experiencing residual Excessive Daytime Sleepiness (EDS) despite treatment with CPAP therapy. At the end of the 12-week treatment period, patients receiving pitolisant scored lower on the Epworth Sleepiness Scale used to measure EDS compared to those in the placebo group, and this difference was statistically significant (p=0.007). Additionally, safety and tolerability were consistent with results from global clinical studies.
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 .
SOURCE Viatris Inc.