Organon Announces US FDA Has Accepted for Review a Supplemental New Drug Application for MIUDELLA®, a Hormone-Free Intrauterine Device

About this update from Organon & Co.

Sebela's sNDA Seeks to Extend Approved Duration of Use from 3 to 6 Years JERSEY CITY, N.J., September 14, 2026 --( BUSINESS WIRE )--Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the US Food and Drug Administration (FDA) has accepted for review Sebela Women's Health's supplemental New Drug Application (sNDA) for MIUDELLA® (copper intrauterine system) for an extended duration of use for up to 6 years with Prescription Drug User Fee Act (PDUFA) action expected in the second quarter of calendar year 2027. In June of 2026, Organon completed its agreement to exclusively license global rights to Sebela's MIUDELLA. MIUDELLA is a hormone-free, copper intrauterine device (IUD) indicated for the prevention of pregnancy in females of reproductive potential for up to 3 years and is anticipated to be commercially available in late 2026. The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS), which is open for enrollment at www.miudellarems.com . The website enables healthcare providers, healthcare settings, and eligible specialty pharmacies to complete the certification and enrollment activities required to support the dispensing and insertion of MIUDELLA. The purpose of the MIUDELLA REMS is to mitigate the risk of complications due to the improper insertion of MIUDELLA by untrained healthcare providers. Please see Important Safety Information below including Boxed Warning. "The FDA's acceptance for review of this supplemental application represents an important milestone as we work to broaden birth control options for women," said Juan Camilo Arjona Ferreira, MD, Head of Research & Development and Chief Medical Officer at Organon. "If approved, MIUDELLA would offer up to six years of hormone-free contraception and the potential to expand a woman's contraceptive choices." "Women deserve contraceptive options that reflect their individual needs and preferences," stated Kelly Culwell, MD, Chief Medical Officer and Head of Research and Development at Sebela Women's Health. "FDA's acceptance for review of this supplemental application reflects the dedication of the investigators and more than 1,900 women who participated in Miudella's clinical trials. We look forward to working with Organon to expand access to Miudella." About MIUDELLA MIUDELLA was investigated in three clinical trials in the US in 1,904 women aged 17 to 45 years. The Phase 3 prospective, multicenter, single-arm, open-label study was conducted in 42 centers in the US with a primary endpoint of contraceptive efficacy through 3 years of use as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year).1 In the efficacy cohort of women aged 17 to 35 years from the Phase 3 study (n=1397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60)—in other words, 99% effective, with an overall placement success rate of ~99%. The most common adverse reactions (≥5%) observed in clinical trials were heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia. In the first year, 8.5% of participants across all three studies discontinued treatment due to bleeding or pain adverse events, which decreased to 3.2% by year 3. Expulsion rates ranged from 1.9% in year 1 to 0.9% in year 3. Indication Selected Safety Information WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION CONTRAINDICATIONS WARNINGS AND PRECAUTIONS ADVERSE REACTIONS Before prescribing MIUDELLA, please read the full Prescribing Information , including Boxed Warning. About Organon Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women's Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately, or differently affect women, while expanding access to essential treatments in over 140 markets. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at http://www.organon.com and follow us on LinkedIn , Instagram , X , YouTube , TikTok and Facebook . About Sebela Pharmaceuticals At Sebela Pharmaceuticals, we are building a leading gastroenterology company in the US and developing innovative products in women's health. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has been innovating, developing, manufacturing, and commercializing gastroenterology products for over 40 years. Braintree has filed a NDA with FDA for tegoprazan, it's lead program in GERD. In 2025 Sebela Women's Health obtained FDA approval for Miudella (copper-containing intrauterine system), the first non‑hormonal intrauterine device (IUD) for contraception approved in over 40 years. Sebela Pharmaceuticals has operations in Roswell, GA; Braintree, MA; and Dublin, Ireland. For more information, visit www.sebelapharma.com . Cautionary Note Regarding Organon's Forward-Looking Statements Except for historical information, this press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the potential benefits of Organon's exclusive license of global rights to MIUDELLA® and expectations regarding the timing of commercialization thereof. Forward-looking statements may be identified by words such as "anticipated," "may," "will," and "expected," among others. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, weakening of economic conditions that could adversely affect the level of demand for MIUDELLA®; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and healthcare reform, pharmaceutical pricing and reimbursement, access to the company's products, international reference pricing, including most-favored-nation drug pricing, and other pricing related initiatives and policy efforts; the impact of tariffs and other trade restrictions or domestic sourcing requirements; expanded brand and class competition in the markets in which the company operates; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to the company; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties, including Sebela Pharmaceuticals; the impact of higher selling and promotional costs; efficacy, safety or other quality concerns with respect to the company's marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes or declining sales; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing healthcare insurance coverage; the failure by the company or its third party collaborators and/or their suppliers to fulfill their or their regulatory or quality obligations; and volatility of commodity prices, fuel, and shipping rates that impact the costs and/or ability to supply the company's products. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's filings with the SEC, including the company's most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC's Internet site ( www.sec.gov ). References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites. Sebela Forward-Looking Statement This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sebela Pharmaceuticals, Sebela Women's Health and Braintree Laboratories under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "may," "will," "forecast," "estimated," "expected," and "intend," among others. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development, launch, introduction and commercial potential of Miudella; growth and opportunity, including peak sales and the potential demand for Miudella, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development and commercialization of new products. There are no guarantees that Miudella will prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and neither Sebela Pharmaceuticals, Sebela Women's Health nor Braintree Laboratories agree to undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. 1Creinin MD, Gawron LM, Roe AH, et al. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception . 2025;143:110771. doi:10.1016/j.contraception.2024.110771 US-MIU-110073 09/2026 View source version on businesswire.com: https://www.businesswire.com/news/home/20260914839018/en/ Contacts Media Contacts: Janine Colavita (732) 861-3806 Karissa Peer (614) 314-8094 Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129

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