Announcement • Sep 14

Organon Announces US FDA Accepts Supplemental New Drug Application for Miudella Copper Intrauterine System

Organon 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. The purpose of the MIUDELLA REMS is to mitigate the risk of complications due to the improper insertion of MIUDELLA by untrained healthcare providers. 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). 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. MIUDELLA is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years. Improper insertion of intrauterine systems, including MIUDELLA, increases the risk of complications. Proper training prior to first use of MIUDELLA can minimize the risk of improper insertion. MIUDELLA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIUDELLA REMS program to ensure all healthcare providers are trained on the proper insertion of MIUDELLA prior to first use. Use of MIUDELLA is contraindicated when 1 or more of the following conditions exist: pregnancy or suspicion of pregnancy; congenital or acquired abnormalities of the uterus, including leiomyomas, resulting in distortion of the uterine cavity; acute pelvic inflammatory disease (PID); postpartum endometritis or postabortal endometritis in the past 3 months; known or suspected uterine or cervical malignancy; for use as postcoital contraception (emergency contraception); uterine bleeding of unknown etiology; untreated acute cervicitis or vaginitis or other lower genital tract infection; conditions associated with increased susceptibility to pelvic infections; Wilson's disease; a previously placed IUS that has not been removed; hypersensitivity to any component of MIUDELLA including to polypropylene, copper, nitinol, an alloy of nickel and titanium, or any of the trace elements present in the copper component of MIUDELLA. Persons with allergic reactions to these components may suffer an allergic reaction to this intrauterine system. Prior to placement, patients should be counseled on the materials contained in the IUS, as well as potential for allergy/hypersensitivity to these materials. Risk of Complications Due to Improper Insertion: Improper insertion of IUSs, including MIUDELLA, increases the risk of perforation, infection, undiagnosed abnormal bleeding, pregnancy loss (if pregnancy occurs with IUS in situ), and expulsion. Proper training prior to first use of MIUDELLA can minimize the risk of improper insertion. MIUDELLA is available only through a restricted program under a REMS. MIUDELLA REMS: MIUDELLA is only available through a restricted program under a REMS called MIUDELLA REMS Program to ensure healthcare providers are trained prior to first use. Notable requirements include the following: healthcare providers must be certified with the program by enrolling and completing training on the proper insertion of MIUDELLA prior to first use. Pharmacies and healthcare settings that dispense MIUDELLA must be certified by enrolling in the REMS and must only dispense MIUDELLA to certified healthcare providers. Ectopic Pregnancy: Promptly evaluate females who become pregnant for ectopic pregnancy while using MIUDELLA. Ectopic pregnancy may require surgery and may result in loss of fertility. Intrauterine Pregnancy: Increased risk of spontaneous abortion, septic abortion, premature delivery, sepsis, septic shock, and death if pregnancy occurs. Remove MIUDELLA if pregnancy occurs with MIUDELLA in place and the thread ends are visible or can be retrieved from the cervical canal. Sepsis: Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other IUSs; strict aseptic technique is essential during insertion. Pelvic Infection: Promptly examine users with complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, genital lesions or sores after insertion of MIUDELLA. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. Remove MIUDELLA in cases of recurrent PID or endometritis, or if an acute pelvic infection is severe or does not respond to treatment. Subclinical PID: PID may be asymptomatic but still result in tubal damage and its sequelae. Perforation: Partial or total perforation of the uterine wall or cervix may occur during insertions, although the perforation may not be detected until sometime later. Perforation may also occur at any time during IUS use. Perforation that results in embedment or translocation may reduce contraceptive efficacy and result in pregnancy. Risk is increased if inserted in postpartum and lactating females and may be increased if inserted in females with fixed, retroverted uteri or noninvoluted uteri.

Organon & Co. Stock Price

OGN Share Price Performance

OGN Community Narratives

Leadership Changes And Regulatory Concerns Will Shape Near-Term Market Prospects

Rising Women's Health Demand And Telemedicine Will Fuel Global Access

Global Pricing Pressures And Patent Cliffs Will Weaken Margins

Rising Women's Health Demand And Telemedicine Will Fuel Global Access

Global Pricing Pressures And Patent Cliffs Will Weaken Margins

Leadership Changes And Regulatory Concerns Will Shape Near-Term Market Prospects

Trending Discussion

Recently Updated Narratives

OGN: Takeover Interest And Licensing Pipeline Will Shape Balanced Future Outlook

OGN: Takeover Bid And Mixed Ratings Will Likely Cap Share Upside

OGN: Takeover Bid And Mixed Ratings Will Constrain Future Share Upside

Snowflake Analysis

Organon & Co. Key Details

About OGN

Recent OGN News & Updates

FDA Reviews Organon’s Bid to Extend MIUDELLA Use Period to Six Years

Organon Announces US FDA Accepts Supplemental New Drug Application for Miudella Copper Intrauterine System

Consensus EPS estimates fall by 12%

Recent updates

Organon & Co. Competitors

United Therapeutics

Viatris

Medpace Holdings

Revvity