공시 • Jan 17
Organon Announces Us Food and Drug Administration Approval of Supplemental New Drug Application Extending Time of Use of Nexplanon®? (Etonogestrel Implant) 68 Mg Radiopaque
Organon announced that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON®? (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. During the clinical trial to assess the contraceptive efficacy and safety of extended use (years 4 and 5), no pregnancies were reported and there were no new safety findings. Additionally, the study enrolled women with a range of body mass index (BMI) values (17.2 to 64.3 kg/m2), with 38.1% of them having a BMI 30 kg/m2. No pregnancies were reported during this period, resulting in a PI of 0.0 (95% CI: 0.00, 0.69) pregnancies per 100 women-years of use, and there were no new safety results. A REMS is a strategy used by the FDA to manage known or potential risks associated with a product. To mitigate complications due to improper insertion and removal, the FDA is requiring the implementation of a REMS program for NEXPLANON. NEXPLANON will only be available in the US through the NEXPLANON REMS program, which is planned to be available starting on February 23, 2026. Clinical Trial Experience: The most common adverse reaction causing discontinuation of use of the implant in 3-year clinical trials was change in menstrual bleeding patterns (11.1%). The most common adverse reactions (5%) reported in these clinical trials were headache (24.9%), vaginitis (14.5%), weight increase (13.7%), acne (13.5%), breast pain (12.8%), abdominal pain (10.9%), and pharyngitis (10.5%). In a separate clinical trial to assess contraceptive efficacy and safety of NEXPLANON beyond 3 years, up to 5 years, a similar adverse reaction profile was observed as in Years 1 through 3. R risks and uncertainties include, but are not limited to, an inability to grow the market for NEXPLANON as expected; expanded brand and class competition in the markets in which Organon operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the US or other governments; changes in US and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon's customers and business partners; economic factors over which Organon relies on for its business growth; 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; 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 health care reform, pharmaceutical pricing and reimbursement, access to its products, international reference pricing, including Most-Favored-Nation drug pricing, and other pricing-related initiatives and policy efforts; an inability to fully execute on Organon's product development and commercialization plans; manufacturing difficulties or delays; disruptions at the US Food and Drug Administration, the US Securities and Exchange Commission (the "SEC") and other US and comparable foreign government agencies; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon's business; efficacy, safety or other quality concerns with respect to Organon'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.