Viatris Inc., a global healthcare company, announced four significant regulatory achievements across its worldwide pipeline. The U.S. Food and Drug Administration approved the company’s octreotide acetate for injectable suspension, a generic version of Sandostatin LAR Depot. This treatment is indicated for patients who have previously tolerated Sandostatin injections and helps manage acromegaly, severe diarrhea or flushing caused by metastatic carcinoid tumors, and profuse watery diarrhea associated with vasoactive intestinal peptide secreting tumors.
In addition, the FDA has accepted for review the new drug application for Viatris’s investigational low dose estrogen weekly patch containing 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol for contraception. The NDA was submitted under the FDA’s 505(b)(2) pathway, with a target action date of July 30, 2026. The patch is designed for women of childbearing potential with a BMI under 30 kg/m² who prefer a non-invasive, reversible contraceptive option with a lower estrogen dose. The application is supported by Phase 3 Luminous Study results, which demonstrated strong efficacy, safety, and adhesion performance.
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Viatris also received FDA clearance for its investigational new drug application for MR-146, a gene therapy candidate using the Enriched Tear Film Adeno-Associated Virus platform to treat neurotrophic keratopathy. The company plans to initiate the Phase 1/2 CORVITA trial for MR-146 in patients with this rare corneal disease in the first half of 2026. Neurotrophic keratopathy affects around 73,000 people in the United States and results in progressive corneal damage caused by conditions such as viral infections, diabetes, multiple sclerosis, chemical burns, dry eye, or corneal surgery. MR-146 delivers human Nerve Growth Factor directly to the lacrimal gland to support corneal healing and represents the first of several potential applications for this platform.
In Japan, the Pharmaceuticals and Medical Devices Agency accepted Viatris’s new drug application for pitolisant to treat obstructive sleep apnea syndrome. The submission follows positive Phase 3 results in Japanese patients with residual excessive daytime sleepiness despite CPAP therapy. After 12 weeks of treatment, patients receiving pitolisant showed significant improvements on the Epworth Sleepiness Scale compared to placebo. Safety and tolerability were consistent with global studies. Viatris remains on track to submit a separate Japanese NDA for narcolepsy by the end of the year.
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Philippe Martin, Chief Research and Development Officer at Viatris, highlighted that these regulatory achievements mark a year of substantial progress in the company’s research and development efforts. He noted that the milestones demonstrate Viatris’s scientific and regulatory capabilities as well as its commitment to addressing unmet medical needs worldwide. Martin emphasized that the company will continue collaborating with health authorities globally to advance its pipeline and deliver innovative treatments for patients in 2026 and beyond.
The approval of octreotide acetate for injectable suspension represents Viatris’s fourth injectable FDA approval in 2025 following iron sucrose, paclitaxel, and liposomal amphotericin B. This achievement underscores the company’s ability to navigate complex regulatory pathways and expand its generics portfolio with high-value, technically complex products. The low dose estrogen weekly patch offers a lifecycle advancement of Viatris’s existing transdermal contraceptive technology and provides a convenient option for women seeking a weekly, non-invasive method.
Overall, these milestones reflect Viatris’s ongoing commitment to developing innovative therapies and expanding access to high-quality medications across multiple therapeutic areas. The company continues to focus on delivering safe, effective, and patient-friendly solutions while strengthening its global footprint in research, development, and commercialization.
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