Viatris Achieves Multiple Regulatory Milestones Across Gene Therapy, Contraception and Sleep Disorder Treatments

Viatris Inc. (VTRS) has announced a series of significant regulatory advances spanning its diverse pharmaceutical pipeline, marking progress in rare disease treatments, women’s health, and neurological disorders.

FDA Greenlights Generic Injectable for Rare Endocrine Disorder

The company secured FDA approval for octreotide acetate for injectable suspension, positioning itself as a generic alternative to the widely prescribed Sandostatin LAR Depot. This long-acting formulation addresses symptom management in rare conditions, particularly acromegaly—a disorder characterized by excessive growth hormone production. The approval represents Viatris’ fourth injectable clearance this year, joining approvals for iron sucrose, paclitaxel, and liposomal amphotericin B, underscoring the company’s expanded footprint in the injectables market.

Contraceptive Patch Advances Through FDA Review Process

A pivotal development for women’s reproductive health came as the FDA accepted Viatris’ New Drug Application for a low-dose estrogen transdermal contraceptive patch. The weekly dosing formulation combines 150 mcg norelgestromin with 17.5 mcg ethinyl estradiol, offering a non-invasive reversible contraceptive option. The application targets women of childbearing age with a BMI below 30 kg/m² who are candidates for combined hormonal contraception and seek convenient patch-based delivery over daily pills. The FDA set a targeted review completion date of July 30, 2026, marking an important milestone for this innovative patch contraceptif approach in the North American market.

Gene Therapy Moves Toward Clinical Testing for Corneal Disease

Viatris obtained FDA clearance for the investigational new drug application of MR-146, an adeno-associated virus (AAV) gene therapy candidate designed to treat neurotrophic keratopathy (NK)—a rare degenerative corneal condition affecting approximately 73,000 Americans. The disease causes progressive corneal damage and poses significant sight-loss risks. The company plans to launch its Phase 1/2 clinical trial called CORVITA during the first half of 2026, advancing a novel treatment avenue for this currently underserved patient population.

Sleep Apnea Treatment Gains Regulatory Traction in Japan

In parallel regulatory progress, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) accepted Viatris’ new drug application for pitolisant targeting obstructive sleep apnea syndrome (OSAS). The application draws support from Phase 3 clinical data demonstrating treatment efficacy in Japanese patients with residual excessive daytime sleepiness despite CPAP therapy. At the 12-week endpoint, pitolisant-treated patients showed statistically significant improvements on the Epworth Sleepiness Scale compared to placebo (p=0.007). The company plans to file an additional PMDA application for pitolisant in narcolepsy by year-end, expanding the therapeutic indication in the Japanese market.