Nexplanon Now Approved for 5-Year Pregnancy Prevention by FDA

The FDA has extended approval of Nexplanon (etonogestrel implant) for pregnancy prevention in women of reproductive age from 3 years to 5 years.Nexplanon is a subdermal progestin implant that prevents pregnancy by:

• Inhibiting ovulation

• Thickening cervical mucus

• Altering the endometrium

This update allows longer contraceptive protection without the need for earlier replacement.

The sNDA extends the duration of use of NEXPLANON for up to five years, an extension of the previous three-year indication. 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.

“Today marks an important milestone for women seeking a highly effective long-acting reversible contraceptive option, as well as another advancement in Organon’s women’s health franchise,” said Organon’s Head of Research and Development and Chief Medical Officer, Juan Camilo Arjona Ferreira, MD. “The sNDA approval of an extended duration up to five years, along with data about the use of NEXPLANON in women with varying BMIs, including women with overweight or obesity, is a testament to Organon’s commitment to inclusive and comprehensive women’s healthcare.”

In addition, this approval includes a new Risk Evaluation and Mitigation Strategy (REMS) program in the US to mitigate complications due to improper insertion and removal.2 This REMS program will enhance Organon’s existing Clinical Training Program (CTP) and controlled distribution program, which has been in place since 2006, by instituting important proactive measures to certify providers in the proper insertion and removal of our product. See additional safety information below.

“The updated label for NEXPLANON reflects the diversity of patients we see every day—women throughout their reproductive ages, those seeking a long-acting option of up to five years, those who prefer birth control that goes in the arm rather than the uterus, and women across a wide range of BMIs,” said Anita Nelson, MD, Professor, Obstetrics and Gynecology at Western University of Health Sciences. “The REMS program builds on existing training requirements to ensure providers maintain the highest standards for insertion and removal, reinforcing confidence and best clinical practice.”

About the Extended-Use Trial for NEXPLANON

The contraceptive efficacy of NEXPLANON during use from 3 to 5 years was evaluated in a multicenter, single-arm, open-label study (NCT04626596) conducted in the United States.1 A total of 399 women were evaluated, having a mean age of 27 years, ranging from 18 to 35 years, and having been using NEXPLANON for 36 months (± 2 weeks) from the date of insertion at the time of enrollment. Participants were 74.2% White, 16.8% Black/African American, 3.8% Asian, 1.3% American Indian or Alaska Native, 0.5% Native Hawaiian or Other Pacific Islander, and 3.5% multiple or missing races. The mean BMI was 29.4 kg/m2 (range: 17.2-64.3 kg/m2), and the mean weight was 78.7 kg (range: 40.8-180.8 kg). One hundred fifty-two participants (38.1%) had a BMI ≥30 kg/m2, including 40 participants (10.0%) with a BMI ≥40 kg/m2.

The primary efficacy endpoint was the Pearl Index (PI) at years 4 and 5. 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 findings.