The US Food and Drug Administration has accepted for review a supplemental New Drug Application (sNDA) filed by Organon (NYSE: OGN) to extend the approved duration of use for MIUDELLA, a hormone-free copper intrauterine device, from three to six years.

Organon completed its agreement in June 2026 to exclusively license global rights to Sebela Women’s Health’s MIUDELLA. The product is currently indicated for pregnancy prevention for up to three years and is anticipated to be commercially available in late 2026. The FDA’s Prescription Drug User Fee Act (PDUFA) action date for this supplemental application is expected in the second quarter of calendar year 2027.

Clinical Efficacy and Safety Data

MIUDELLA was investigated in three US clinical trials involving 1,904 women aged 17 to 45 years. The Phase 3 prospective, multicenter study was conducted across 42 centers with a primary endpoint of contraceptive efficacy through three years of use.

In the efficacy cohort of women aged 17 to 35 years (n=1,397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78). The cumulative three-year Pearl Index stood at 1.05 (95% CI, 0.66-1.60), indicating approximately 99% effectiveness. The overall placement success rate was roughly 99%.

Discontinuation due to bleeding or pain adverse events decreased from 8.5% in the first year to 3.2% by year three. Expulsion rates ranged from 1.9% in year one to 0.9% in year three. Common adverse reactions observed in ≥5% of participants included heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia.

Regulatory and Safety Requirements

MIUDELLA carries a Risk Evaluation and Mitigation Strategy (REMS) to mitigate complications from improper insertion by untrained healthcare providers. The REMS program requires certification and enrollment for healthcare providers, settings, and eligible specialty pharmacies before dispensing or insertion.

Key safety warnings include risks associated with improper insertion, such as perforation, infection, and expulsion. The device is contraindicated in cases of pregnancy, uterine abnormalities, acute pelvic inflammatory disease, Wilson’s disease, and hypersensitivity to copper or other components. Patients using MIUDELLA must be evaluated promptly for ectopic pregnancy if conception occurs.

What the Numbers Show

The clinical data reveals a significant improvement in tolerability over time. The discontinuation rate due to adverse events more than halved, dropping from 8.5% in the first year to 3.2% by the third year. This divergence suggests that while initial side effects like bleeding and pain are common, patient retention improves substantially as users adjust to the device over the long term.

Organon, a global healthcare company focused on women’s health and general medicines, has declared a quarterly dividend of $0.02 for each issued and outstanding share of its common stock. The Board of Directors announced the distribution, which provides direct cash returns to investors holding the stock as of the record date. This declaration underscores the company’s commitment to shareholder value amidst its mission to deliver impactful medicines across more than 140 markets.

The dividend is payable on September 10, 2026. To qualify for this payment, stockholders must hold their shares at the close of business on August 14, 2026. Investors should ensure their holdings are registered correctly before the record date to receive the distribution.

Dividend Details

The following table outlines the key dates and amounts associated with this quarterly distribution:

Company Overview

Headquartered in Jersey City, New Jersey, Organon operates with a portfolio of over 70 products. Its focus remains on addressing health needs that uniquely, disproportionately, or differently affect women, while also expanding access to essential treatments including biosimilars. The company continues to advance access, affordability, and innovation in healthcare globally.