Home / Health / Pregnancy Implant Extended to 5 Years by FDA
Pregnancy Implant Extended to 5 Years by FDA
20 Jan
Summary
- Nexplanon implant now approved for up to five years of use.
- FDA approval based on trial data showing no pregnancies over 4-5 years.
- Extended use data includes women with varying BMIs, including obesity.
The U.S. Food and Drug Administration (FDA) has granted approval for Organon's Nexplanon contraceptive implant to be used for up to five years. This extension, a notable advancement from its prior three-year duration, offers women an enhanced long-acting reversible contraceptive option. The supplemental New Drug Application (sNDA) was supported by compelling data from a clinical trial assessing Nexplanon's effectiveness in individuals using it for at least 36 months.
The trial's primary objective was to evaluate the Pearl Index (PI) for pregnancy rates at years four and five. Crucially, no pregnancies were recorded during this extended period among the 399 women who participated. The study also encompassed a diverse range of body mass index (BMI) values, from 17.2 to 64.3 kg/m², with a significant portion, 38.1%, having a BMI above 30 kg/m², highlighting its efficacy across varying body types.
This FDA approval signifies a milestone for women's health and Organon's commitment to its dedicated portfolio. Data supporting its use in women with varying BMIs, including those with overweight or obesity, underscores Organon's dedication to inclusive healthcare. This development aligns with the increasing trend of long-acting reversible contraception (LARC) use among U.S. teenagers, as reported by the CDC, showing a rise from 5.8% (2011-2015) to 19.2% (2015-2020).
